Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier

There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF). In order to sell globally, the EU’s CE-marking documentation is a requirement — the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but there are some similarities. And both are moving together in some important areas. 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, TF/DDs?

This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF and the EU MDD’s TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.

Areas Covered in the Session : 

• How to meet and document their differing requirements.
• Required and desirable contents.
• Areas requiring frequent re-evaluation / update.
• Similarities and differences, and future convergences and trends.
• Typical DHF contents.
• Typical Technical File or Design Dossier 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.
• Where the Device Master Record / Device History Record “tie in”.
• Differing approaches to records audits by the U.S. FDA and an EU Notified Body

Who Should Attend:

This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. Its principles apply to personnel / companies in the Medical Devices, Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include: 

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors
• All personnel especially involved in device development, regulatory compliance and documentation.

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.