DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

Global Medical Device Podcast · 2 Mar 2023 · 27m · Episode 308

What this episode covers

Laura Court, a Medical Device Guru at Greenlight Guru, explains the distinct roles and interactions of the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) in medical device development. She emphasizes that the DHF is the history of product development, the DMR is the manufacturing recipe, and the DHR is the batch-specific production record. Court advises engineers to start documenting early, use multiple design reviews to catch stakeholder input, and leverage tribal knowledge from manufacturing teams to improve processes.

Most relevant to

established companies

Topics

Mentioned

Companies: Greenlight Guru
Also: FDA, ISO 13485

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DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi