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Artificial Intelligence (AI) is no longer a futuristic concept in life sciences — it’s here, reshaping how drugs are developed, reviewed, and marketed. But with innovation comes oversight, and that’s where the FDA draft guidance AI in pharma makes headlines in 2025. For the first time, the FDA is laying down structured expectations around how AI can and should be used across the pharmaceutical value chain.

In the ever-evolving world of medical device regulations, maintaining accurate and compliant documentation is crucial. In this guide, we’ll explore the essential components of design control documentation—DHF, DMR, DHR—under the lens of 21 CFR 820.30 and ISO 13485:2016, particularly section 7.3.

What is DHF, DMR, and DHR in Medical Device Compliance?

 DHF – Design History File

The DHF is a collection of records that describe the design history of a finished medical device. It’s required under 21 CFR 820.30(j) and helps demonstrate that the design was developed in accordance with the approved design plan.

 DMR – Device Master Record

The DMR includes the specifications for manufacturing the device. According to 21 CFR 820.181, it contains the materials, equipment, processes, and labeling required for consistent production.

 DHR – Device History Record

The DHR shows that each device was manufactured according to the DMR. It includes records like production dates, quantities, and acceptance records, as required by 21 CFR 820.184.

 Understanding 21 CFR 820.30 – Design Controls

The FDA’s 21 CFR Part 820.30 sets design control requirements that manufacturers must follow during medical device development. It emphasizes risk management, design reviews, verification, validation, and design transfer.

Compliance with 21 CFR 820.30 ensures:

Product safety and effectiveness

Consistency in design and manufacturing

Easier FDA inspections and audits

 ISO 13485:2016 Section 7.3 – Design and Development

ISO 13485 section 7.3 outlines design and development processes that align with international medical device QMS standards. While 21 CFR 820.30 is U.S.-centric, ISO 13485:2016 is globally recognized.

Key elements include:

Design planning

Design input & output

Design verification & validation

Design transfer

Design changes

Record keeping aligned with DHF, DMR, and DHR

DHF, DMR, DHR – How They Work Together

DHF shows how the device was designed

DMR guides how the device is built

DHR proves the device was made correctly

Together, they form the backbone of your QMS documentation.

Why Documentation Matters in 2025 and Beyond

With the FDA increasing scrutiny and ISO standards being updated, proper documentation under 21 CFR 820.30 and ISO 13485.7.3 is more important than ever. Medical device manufacturers must align their internal processes with both domestic and international regulations to ensure:

Product approval

Risk management

Market access in U.S. and EU

Audit readiness

 Join Our Upcoming Webinar on Medical Device Documentation

Learn directly from compliance experts about how to implement DHF, DMR, and DHR frameworks in alignment with 21 CFR 820.30 and ISO 13485

Conclusion