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Medical device manufacturing is not an easy process. If anything goes wrong, the entire batch of products is at stake. Is there any solution to it? DHF, DMR, and DHR are the three Ds of medical device that needs to be managed carefully.

Even though these files serve different purposes, it is essential to understand how they are mutually inclusive for effective technical documentation. This seminar offers a deeper insight into the documentation part of medical device manufacturing. Moreover, the seminar will cover the latest requirements proposed by FDA and European Union.

Let’s dive deeper into the topics covered! 

Course Overview 

Breaking down each of these terms for a better understanding of freshers into medical device manufacturing.

·      Design History File (DHF): Includes an entire history of the device’s design, which justifies the currently approved design.

·      Device Master Record (DMR): Associated with device production and highlights the requirements like material, equipment, and surroundings.

·      Device History Record (DHR): Contains production-related documents which consist of dates, quantity, and labels of final products.

It is essential to have proper knowledge of technical documentation because these are submitted to the FDA. Additionally, these play an important role in pre-market approval of the device. It is crucial for regulatory compliance and this course focuses on future trends and the typical table of contents.

The core purpose of this seminar is to highlight the general safety and performance requirements. Moreover, the coach pays special attention to the file auditing process by FDA and notified the body to make the execution of the concept easier for professionals.

Below are the topics discussed in the seminar:

Session 1

  • Introduction
  • Design Control Under 21 CFR 820.30
  • Design and Development Planning under ISO 13485:2016 7.3
  • The U.S. FDA's DHF
  • The EU MDR's D&DPF
  • MDR's "General Safety and Performance Requirements"
  • Device Classification - U.S. FDA vs. EU MDD
  • Design Files' "Typical" Contents
  • The DMR and DHR / Lot / Batch Record TD Expected Contents

Session 2

  • Risk Management / File Under ISO 14971
  • Narrative
  • Hazzard Analysis
  • FTA
  • D-, P-, and U-FMECA's
  • Report

Session 3

  • Human Factors / Use Engineering Under IEC 62366-1:2015
  • The User Interface
  • The 9 Stages
  • The HF / UE File

Session 4

  • Putting It All Together
  • Design Control
  • The Team
  • Concurrent Compilation of the Three Files
  • Derivative Documents Development
  • Completion
  • FDA and NB Audit Focus
  • Final Q & A

Who will benefit from the course? 

·      Quality and Research Analyst: To verify regulatory compliance effectively and document everything as per the norms.

·      R&D Professionals: Incorporate device history and master records for innovative changes

·      Engineering: To understand the mechanism and design effectively

·      Production: To be able to create an estimate of the project and timeline of the manufacturing process

·      Marketing: Knowing the in and out of a product will allow these professionals to execute marketing strategies effectively 

People Also Ask

Q1 Are DHF, DHR, and DMR interrelated?

While DHF, DHR, and DMR are not directly interrelated, these are mutually inclusive when it comes to device manufacturing and production. Any professional closely related to the biomedical device manufacturing process needs to know this technical documentation deeply.

Q2 How does proper knowledge of DMR help?

Detailed procedures related to design, documents, and tools help during inspection approvals, quality assurance, and packaging verification. Having a sound knowledge of DMR ensures the manufacturing department not only builds the device but also knows the maintenance techniques.

Q3 Is DHR important for releasing the product?

Yes. There is a strict requirement for reviewing committee to look at all the aspects of the product before its release into the market. It is the investigator’s responsibility to look at the DHR and the DMR and compare it.

Faculty John E Lincoln

Faculty John E. Lincoln

Principal of J. E. Lincoln and Associates LLC

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.


RAPS - This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria