Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files – The US FDA and EU MDR Requirements
Ensure Global Compliance With Expert Insights On Key Documentation!
Instructor :
John E Lincoln
Webinar ID:
13909
Date: APR 15, 2025 (TUE)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Understand Key Differences Between DHF, DMR, DHR, And TD
- Navigate FDA And EU MDR Documentation Requirements Confidently
- Apply Design Control Principles To Meet Regulatory Expectations
- Build Audit-Ready Documentation With Accurate File Structures
- Align Product Files With Global Compliance And Quality Standards
- Manage Documentation Updates For Lifecycle And Market Changes
- Integrate Team Efforts For ….
-
- Understand Key Differences Between DHF, DMR, DHR, And TD
- Navigate FDA And EU MDR Documentation Requirements Confidently
- Apply Design Control Principles To Meet Regulatory Expectations
- Build Audit-Ready Documentation With Accurate File Structures
- Align Product Files With Global Compliance And Quality Standards
- Manage Documentation Updates For Lifecycle And Market Changes
- Integrate Team Efforts For Streamlined Regulatory Submissions
- Identify And Avoid Common Gaps In File Preparation
Course Description
Navigating global regulatory requirements for medical devices demands a deep understanding of critical documentation standards.
This comprehensive training dives into the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical Documentation Files, covering both US FDA and EU MDR requirements.
Participants will explore:
-
- The distinct purposes and regulatory goals of each documentation type
- Key differences in FDA vs. EU MDR device classification systems
- Required and recommended content structures for compliance
- Typical Table of Contents for DHF and Technical Documentation Files
- The role and relevance of the General Safety and Performance Requirements (formerly “Essential Requirements”)
The session will also examine:
-
- Parallel approaches to documentation and product development
- Criteria for self-declared changes vs. those needing Notified Body review
- Strategies for managing frequent updates and re-evaluations
- Future trends in documentation and compliance practices
- Contrasting audit approaches by the FDA and EU Notified Bodies
By demystifying these critical regulatory artifacts, the course equips professionals with the knowledge to build robust, inspection-ready documentation that aligns with evolving global standards.
Enroll Now!
Navigating global regulatory requirements for medical devices demands a deep understanding of critical documentation standards.
This comprehensive training dives into the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical Documentation Files, covering both US FDA and EU MDR requirements.
Participants will explore:
-
- The distinct purposes and regulatory goals of each documentation type
- Key differences in FDA vs. EU MDR device classification systems
- Required and recommended content structures for compliance
- Typical Table of Contents for DHF and Technical Documentation Files
- The role and relevance of the General Safety and Performance Requirements (formerly “Essential Requirements”)
The session will also examine:
-
- Parallel approaches to documentation and product development
- Criteria for self-declared changes vs. those needing Notified Body review
- Strategies for managing frequent updates and re-evaluations
- Future trends in documentation and compliance practices
- Contrasting audit approaches by the FDA and EU Notified Bodies
By demystifying these critical regulatory artifacts, the course equips professionals with the knowledge to build robust, inspection-ready documentation that aligns with evolving global standards.
Enroll Now!
Why you should attend
In today’s global regulatory landscape, misaligned documentation can result in costly delays, failed audits, or even market exclusion.
This training addresses the critical challenge of understanding and aligning the DHF, DMR, DHR, and Technical Documentation Files—each essential to meeting FDA and EU MDR requirements.
Whether you’re preparing for FDA inspections or pursuing CE marking in the EU, this course delivers the clarity and structure needed to confidently manage both.
You’ll gain:
-
- A clear roadmap for integrating U.S. and EU documentation standards
- Insights into how DHF and Technical Files are converging
- Practical strategies for managing DHF, DMR, and DHR in parallel
- Tools to streamline updates and maintain audit-ready files
Stay ahead of evolving requirements and ensure your teams are documentation-ready for global success.
Join Now!
In today’s global regulatory landscape, misaligned documentation can result in costly delays, failed audits, or even market exclusion.
This training addresses the critical challenge of understanding and aligning the DHF, DMR, DHR, and Technical Documentation Files—each essential to meeting FDA and EU MDR requirements.
Whether you’re preparing for FDA inspections or pursuing CE marking in the EU, this course delivers the clarity and structure needed to confidently manage both.
You’ll gain:
-
- A clear roadmap for integrating U.S. and EU documentation standards
- Insights into how DHF and Technical Files are converging
- Practical strategies for managing DHF, DMR, and DHR in parallel
- Tools to streamline updates and maintain audit-ready files
Stay ahead of evolving requirements and ensure your teams are documentation-ready for global success.
Join Now!
Areas Covered
1. Introduction to Global Regulatory Documentation
-
- Understanding the role of Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical Documentation Files
- Overview of FDA and EU MDR expectations
2. Device Classification Schemes
-
- Comparison of U.S. FDA vs. EU MDR classification models
- How classification impacts documentation requirements
3. Regulatory Philosophies: U.S. vs. EU
-
- Design Control “Over Time” (FDA) vs. Snapshot in Time (EU MDR)
- How differing philosophies influence documentation strategy
4. Core Components of Design and Technical Files
-
- Typical DHF contents and expected deliverables
- Required content structure for the Technical File / Design Dossier (TF/DD)
- Structure and purpose of the DMR and DHR, including lot and batch records
5. Documentation Best Practices
-
- Parallel documentation approaches for global alignment
- Cross-functional team collaboration strategies
6. Navigating Audits and Inspections
-
- Key focus areas during FDA inspections
- What Notified Bodies look for during EU MDR audits
- Common documentation pitfalls and how to avoid them
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
1. Introduction to Global Regulatory Documentation
-
- Understanding the role of Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical Documentation Files
- Overview of FDA and EU MDR expectations
2. Device Classification Schemes
-
- Comparison of U.S. FDA vs. EU MDR classification models
- How classification impacts documentation requirements
3. Regulatory Philosophies: U.S. vs. EU
-
- Design Control “Over Time” (FDA) vs. Snapshot in Time (EU MDR)
- How differing philosophies influence documentation strategy
4. Core Components of Design and Technical Files
-
- Typical DHF contents and expected deliverables
- Required content structure for the Technical File / Design Dossier (TF/DD)
- Structure and purpose of the DMR and DHR, including lot and batch records
5. Documentation Best Practices
-
- Parallel documentation approaches for global alignment
- Cross-functional team collaboration strategies
6. Navigating Audits and Inspections
-
- Key focus areas during FDA inspections
- What Notified Bodies look for during EU MDR audits
- Common documentation pitfalls and how to avoid them
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance Professionals In Medical Device Companies
- Regulatory Affairs Managers And Compliance Specialists
- Design And Development Engineers In Life Sciences
- Documentation And Technical File Coordinators
- R&D Teams In FDA-Regulated Environments
- Professionals Preparing For FDA Or EU Audits
- Manufacturing And Operations Leaders In MedTech
- Consultants Supporting Regulatory Documentation Processes
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance Professionals In Medical Device Companies
- Regulatory Affairs Managers And Compliance Specialists
- Design And Development Engineers In Life Sciences
- Documentation And Technical File Coordinators
- R&D Teams In FDA-Regulated Environments
- Professionals Preparing For FDA Or EU Audits
- Manufacturing And Operations Leaders In MedTech
- Consultants Supporting Regulatory Documentation Processes
Instructor Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have 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, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
