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!
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.
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.
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.
Course Content
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
Agenda
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
- Risk Management / File Under ISO 14971
- Narrative
- Hazzard Analysis
- FTA
- D-, P-, and U-FMECA's
- Report
- Human Factors / Use Engineering Under IEC 62366-1:2015
- The User Interface
- The 9 Stages
- The HF / UE File
- 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
Course Provider
John E. Lincoln,
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.
