- Duration: 60 Minutes
- Product Code: GCS14-103R (Recorded)
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
- Applicable statute(s), regulations, and definitions
- Risk management policy
- Risk management plan
- Risk identification, analysis and evaluation
- Risk analysis (severity, probability and detectability)
- Risk control measures
- Risk mitigation
- Risk management tools and methods
- ISO 14971:2007 and EN ISO 14971:2012
- ISO 13485:2003 and EN ISO 13485:2012
- Risk analysis and design control
- Risk analysis versus FMEA
- Risk analysis versus usability
- How to integrate risk management into the device design and development
- Doing risk management right without wasting resources
- Practical aspects (value) of risk management
- Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
- Risk management for IVDs
- Risk analysis versus IEC 60601-1
- Relationship between risk management, complaint handling, MDR and CAPA
About the Intended Attendee(s)
- Regulatory Affairs
- Clinical Affairs
- Senior Management
- Anyone Interested in the Risk Management
About the Seminar Speaker
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 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.
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- Recorded: $249