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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-03-02
- Length: 27m
- Episode: 308
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact
- Listen: https://podcast.greenlight.guru/episode/dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=0) Introduction and Laura Court's Role
- [5:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=324) The DHF: History of Product Development
- [7:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=420) Best Practices for Design Reviews and Documentation
- [11:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=705) The DMR: The Manufacturing Recipe
- [16:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=977) The DHR: Batch-Specific Production Records
- [20:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=1250) Capturing Tribal Knowledge and Feedback Loops
- [24:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact#t=1447) Document Control and Final Advice

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)

## Related episodes from other shows

- [118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su) (Let's Combinate)
- [160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained) (Let's Combinate)
- [187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-07-187-why-drug-and-device-development-use-different-playbooks-qbd-vs-design-contro) (Let's Combinate)
- [136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-15-136-systems-engineering-for-combination-products-user-needs-design-inputs-design) (Let's Combinate)
- [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](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.