Recorded Online Seminar
Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)
- Duration: 60 Minutes
About the Seminar
Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
This presentation is intended to help you understand and adequately implement Medical Device Design Control for manufacturers and relevant stakeholders. In particular, this seminar will discuss the meaning and scope of Design History File (DHF), Device History Record (DHR), Device Master Record (DMR), and relationship between them in detail.
Design control is a subsystem of the quality management systems. Design control involves an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances). Design control offers improved visibility of the design (development) process to the designers and managers.
The value of an adequate design control system includes, but is not limited to, a baseline to review the system at adequate intervals for improvements based on design history, problems, and failures of the design control system. However, in practice, an adequate documentation for DHF, DHR, and DMR has been undervalued, thereby leading to 483s and FDA warning letters. Recently, FDA issued a warning letter to a device manufacturer for design changes made to FDA cleared 510(k)s without submitting a 510(k). Accordingly, it is imperative that device firms implement an adequate design control system.
In this 60-min presentation, seminar speaker will guide you through the details of the necessary elements in the design control systems including, DHF, DHR, and DMR.
About the Areas to Be Discussed
- Applicable Statute(s) and Regulations
- Design Control Elements
- Design History File (DHF): Contents
- Device History Record (DHR): Contents
- Device Master Record (DMR): Contents
- Relationship: DHF, DHR, and DMR
- Location and Organization of Design Control Documents
- Laboratory/Engineering Notebooks
- Notebooks After Employees’ Departure
- Company Policy
- Statements Necessary in the Contracts
- Relationship with ISO 9001 and ISO 13485
- Unique Device Identification (UDI) System Integration
- PASS-IT Suggestions/Recommendations
About the Intended Attendee(s)
- R&D Scientists and Engineers, Managers, Directors, and VPs
- Regulatory Affairs
- Clinical Affairs
- Compliance Officers
- Senior Management
- Anyone Interested in the Subject
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 eight 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. 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. Dr. Lim serves as a member of Advisory Board for inspection insider at FDA News.
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- Recorded: $249