Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) for Medical Devices Training

Device Master Record (DMR) & Device History Record (DHR) Training: Ensuring Compliance & Effective Technical Documentation Course Description

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.

Learning Objectives

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 should Attend?

• Quality and Research Analysts: Learn to verify regulatory compliance efficiently and maintain accurate documentation in accordance with FDA and ISO standards.
• R&D Professionals: Understand how to incorporate Design History Files (DHF) and Device Master Records (DMR) when making innovative changes to devices.
• Engineering Teams: Gain insights into device design and mechanisms to ensure proper documentation and regulatory alignment.
• Production / Manufacturing Professionals: Learn to estimate project timelines and align the manufacturing process with Device History Records (DHR) requirements.
• Marketing Professionals: Acquire a clear understanding of the product’s development and compliance processes, enabling effective marketing strategies grounded in accurate device knowledge.
  

This live training seminar includes the following for each registered attendee:

• A copy of the presentation slides by download
• A certificate of attendance can be downloaded from the WCS Learning Portal following the event
• Q/A Session with the Faculty
• Free Handouts on Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)

How to Attend:

All WCS seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.

Audience Learning Level - Basic to Intermediate 

Hear from Our Learners: Real Success Stories

⭐️⭐️⭐️⭐️⭐️

“This DHF, DMR, and DHR training completely transformed how our team approaches medical device documentation. The practical examples and templates made implementing compliant processes straightforward and efficient.”
— Quality Assurance Manager, Medical Device Company

⭐️⭐️⭐️⭐️⭐️

“I now fully understand the connections between DHF, DMR, and DHR. The course prepared us for FDA and ISO inspections with actionable insights we could immediately apply.”
— Regulatory Affairs Specialist

⭐️⭐️⭐️⭐️⭐️

“The instructor’s clear explanations and real-world scenarios made complex regulatory requirements easy to follow. Our internal audits have improved significantly since attending this course.”
— Design Engineer, Medical Devices

✅ Frequently Asked Questions (FAQ)

1. What is the purpose of this DHF, DMR, and DHR training?

This course helps medical device professionals understand and implement the regulatory requirements for Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) to ensure compliance with FDA 21 CFR Part 820 and ISO 13485 standards.

2. Does this course cover international regulations?

Yes. While the course focuses on FDA 21 CFR Part 820, it also highlights ISO 13485 requirements and best practices for global medical device compliance.

3. Can this training help with FDA or ISO inspections?

Absolutely. The course equips participants with the knowledge and tools to prepare DHF, DMR, and DHR for regulatory inspections and internal audits, helping reduce non-compliance risks.

4. Is prior experience required?

No prior experience is required, but a basic understanding of medical device design and manufacturing is helpful to maximize learning.