Design History Files and Technical Files under US FDA and EU MDD

Instructor: John E Lincoln
Product ID: 701175
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2009

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Read Frequently Asked Questions

This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address.


The U.S. FDA’s Design Control requirements of the QS Regulation mandate the initiation and maintenance of a product Design History File for products to be marketed in the U.S. The European Union’s Medical Device Directive and a company’s Notified Body require a Technical Dossier or Technical File to show compliance to the Essential Requirements of the MDD and associated relavant standards for product to be CE-marked and marked in those countries (and others). Attendees will be helped to see how to understand the similarities and differences of these two complimentarty documents. Attendees will be further helped to comply with the respective requirements and develop compliant files to address either or both.

Areas Covered in the seminar:

  • The U.S. FDA’s DHF’s defined purpose;
  • The EU’s MDD’s defined purpose;
  • Similarities;
  • Differences;
  • Parallel approaches to developing the documents;
  • When to involve teams;
  • What to expect from FDA and NB audits;
  • Approaches to ensure they remain “living (and useful) documents”.

Who will benefit:

  • Senior management, project leaders
  • Regulatory affairs
  • Quality systems personnel:FDA and ISO / MDD / CE-marking compliance
  • R&D and engineering staff
  • All charged with new product development, regulatory submissions, initiating / overseeing regulatory compliance.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Follow us :
Seminars by Ex-FDA Officials
Medical Device Summit 2018

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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