Device manufacturers are required to establish and maintain FDA-compliant quality management systems—wherever it’s appropriate and applicable— including a design control subsystem.
In this audio session, Dr David Lim will throw light on the regulatory requirements for a medical device design control system including design history file (DHF), device history record (DHR), and device master record (DMR). David will provide practical, actionable and sustainable guidance on how to adequately implement design control requirements as a subsystem of the quality management system.
Get familiar with design control requirements including DHF, DHR, and DMR, and learn how to adequately establish and follow design control procedures, to the extent, applicable to your device types in this 60-minute audio conference.
Areas to be covered in this session:
Who should attend:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.