Overview
What are U.S. FDA and EU MDR requirements for DHFs, DMRs, DHRs, and Technical Documents ? Formats, contents, and their commonalities, differences and interrelationships.
This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDR's Technical Documentation -- how to meet and document them. Their differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future convergences and trends. Typical DHF Table of Contents, including Risk Management and Use Engineering. Technical Documentation File Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Parallel approaches to development. The Device Master Record / Device History Record "tie in". Differing approaches to file audits by the U.S. FDA and a Notified Body.
Why Should You Attend
Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. The cGMPs mandate Design Control and the Design History File (DHF); ISO 13485 requires the Design and Development File; both require a Risk Management File (ISO 14971) and Use Engineering File (IEC 62366-1). In order to sell globally, the EU's CE-marking documentation is a requirement -- the old MDD Technical FiIe or Design Dossier, now the newMDR Technical Documentation File . Currently they serve differnt purposes, support different goals, but the TD is moving in the direction of the DHF. And the DHF may soon borrow some features required in the MDR's TD File. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, Technical Files? What are key components of a Risk Mangement File, and a Use Engineering / Human Factors File.
Webinar Takeaway
- The U.S. FDA's DHF
- The EU's MDR and the Technical Documentation File
- Design Contol vs. a Product 'Snapshot in Time'
- DHF /D&DF Required Contents
- The Risk Management File (ISO 14971
- The Use Engineering File (IEC 62366-1)
- TD Expected Contents
- Parallel Approaches to Documentation -- Teams
- The DMR and DHR
- Future Directions
- FDA and NB Audit Focus
Who Will Benefit
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
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All personnel involved in the U.S. FDA-regulated and CE-marking environments. Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF, TD, and then document their decisions in harmony with regulations.
Faculty John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
