How to Establish and Maintain a Design History File for a Medical Device

This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

Why Should You Attend:

This webinar will provide an overview of basic requirements for the content of a medical device Design History File (DHF) to ensure compliance with 21 CFR 820 and ISO 13485:2016 guidelines. It will review potential differences in the requirements between the two regulatory standards.

Attend this webinar to learn how the outputs of risk management activities can affect a medical device’s DHF. It will also cover methods for establishment and ongoing maintenance of the required records.

Areas Covered in the Webinar:

• Records required for the Design History File.
• Whose job is it to establish and maintain the Design History File?
• How to maintain control over the Design History File documents?
• What document control means for DHF documents (records)?
• What are the responsibilities of various development team members – such as R&D/engineering, marketing, quality assurance, project management and executive management?
• Do you consider a marketed medical device’s DHF a static record simply signed off and stored?
• Link to other relevant design files, such as a medical device product Risk Management File

Who Will Benefit:

• R & D Scientists
• Project Managers
• Quality Assurance Personnel
• Document Control Personnel
• Regulatory Affairs Personnel
• Quality Engineers
• Quality System Auditors
• Marketing
• Executive Management

Mary Nunnally
President, Translational Medicine LLC

Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.

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