Share
Apr
9
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Apr 9 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: April 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
May
6
Mon
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
May 6 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
May
7
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
May 7 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jul
2
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Jul 2 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jul
9
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Jul 9 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: April 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Sep
3
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Sep 3 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Oct
8
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Oct 8 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: April 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Nov
5
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Nov 5 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Jan
7
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Jan 7 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: May 6, 2019
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Jan
14
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Jan 14 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: April 9, 2019
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share