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2day Inperson Seminar on The DHF Technical File and Design Dossier Similarities Differences an

8/12/2013 9:00 AM - 6:00 PM


One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The U.S. FDA's CGMPs mandate Design Control and the Design History File (DHF) at 21 CFR 820.30. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier, as described in their Medical Device Directive. What are the requirements for each file? Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the required content, as well as the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

Why should you attend?

This seminar /workshop will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, their similarities, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or Notified-Body reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the U.S. FDA and the EU Notified Body will be discussed.

Course Outline:

Day 1 – 12th September 2013

Lecture 1: The Design Control requirements of the CGMPs, 21 CFR 820.30

Lecture 2: The Design History File - documenting Product Design Control and its nine elements

Lecture 3: The Device Master Record and the Device History Record

Lecture 4: Summary of morning discussion

Lecture 5: Group activity on the 1) The DHF, or 2) The DMR and DHRs

Lecture 6: Review of group activity and Q&A

Day 2 - 13th September 2013

Lecture 7: The EU's Medical Device Directive

Lecture 8: The "Essential Requirements" and their documentation

Lecture 9: The remaining elements of a Technical File / Design Dossier

Lecture 10: ISO 14971:2012, The Product Risk Management File / Report overview

Lecture 11: DHF / TF, DD Trends

Lecture 12: Summary of morning discussion

Lecture 13: Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements

Lecture 14: Review of group activity and Q&A

Lecture 15: Summary of morning discussion

Lecture 16: Course summary discussion

Who Will Benefit:

This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s). This information addresses Medical Device documentation requirements and implementation. The employees who will benefit include:

• Senior and middle management and staff

• Regulatory Affairs


• R&D

• Production Management

• Manufacturing Engineers

• Process Engineers

• Project Managers

• Vendors, sales and marketing

• Any tasked with medical device development, documentation, and regulatory responsibilities

About Speaker: John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, 17 of which as a full-time 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 V&V including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).


Las Vegas | September 12th & 13th, 2013 | 9 AM to 6 PM

Hotel: Hilton Grand Vacations Suites at the Flamingo

Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA

Price: $1,295.00

Register now and save $200. (Early Bird)

Until March 29, Early Bird Price: $1,295.00

from March 30 to April 30, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884



Event Link:


Net Zealous LLC, DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

Learn More: 2day Inperson Seminar on The DHF Technical File and Design Dossier Similarities Differences an

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