Duration: 60 Minutes


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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.

Areas Covered in the Session :

  • Applicable Statute(s) and Regulations
  • Definitions
  • 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

Who Should Attend:

  • R&D Scientists and Engineers, Managers, Directors, and VPs
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • Consultants
  • Contractors
  • Compliance Officers
  • Senior Management
  • Anyone Interested in the Subject

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, 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 and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.