For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.
But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy.

QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond.

Why FDA is doing this

FDA’s move is driven by three key goals:

Harmonization (reduce duplicated systems and audits)

Modern quality thinking (move from “procedures” to “system effectiveness and risk”)

Inspection efficiency (more end-to-end audits)

What inspections may look like under QMSR

Instead of jumping between SOPs, inspections may follow real flows like:
Complaint → Risk Management → CAPA → Design Change → Supplier Impact
The focus becomes traceability, consistency, and risk-based justification.

What companies should do now

To be QMSR-ready, companies should:

Build an ISO 13485-style process map

Make risk visible everywhere, not only in product development

Improve CAPA triage and effectiveness checks

Strengthen design controls (especially software development & V&V)

Train teams on the new “why/how” inspection style

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

📩 If you need help implementing QMSR or preparing your teams for FDA inspections, contact: [email protected]

🌍 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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