Best team setup for Class I (EU) medical device QMS and technical documentation?

Question

We are a small team preparing to set up our Quality Management System (QMS) and Technical Documentation for a Class I medical device in the EU, which includes a hardware component. We are considering several possible team setups:
• Founder + Open Regulatory resources
• Founder + Consultants + Open Regulatory resources
• Founder + QA/Regulatory person (contact point for consultants) + Consultants + Open Regulatory resources
• Other?
What are the pros and cons of each approach? What common pitfalls should be avoided?
We're looking for advice from those with experience in establishing QMS and technical documentation for Class I medical devices in the EU.

Dr. Oliver Eidel · Accepted Answer

If the founders don't have much experience with QMS or regulatory compliance for medical devices, it's really important to build internal expertise in quality management and regulatory affairs. Compliance isn't just a one-off project—it's ongoing, including maintenance, internal audits, and CAPA processes. MDR Article 10 requires you to establish, implement, update, and continually improve a QMS.
Here's a quick rundown of each setup:
• Founder + Open Regulatory: This is fast and low-cost, but very risky unless the founder already has strong regulatory experience. You'll likely miss key details and may struggle to maintain compliance long-term.
• Founder + Consultants + Open Regulatory: Better, as consultants can fill knowledge gaps, but without someone internal to own compliance, you may have issues with follow-through and day-to-day QMS upkeep.
• Founder + QA/Regulatory person (internal contact) + Consultants + Open Regulatory: This is the strongest option. Having someone internal who understands and owns the QMS and regulatory processes means you'll be able to maintain compliance, respond to issues, and keep improving over time. Consultants can then provide targeted expertise.
Common pitfalls include treating compliance as a “set-and-forget” project, not maintaining documentation, and lacking internal ownership, which can hurt you during audits or if issues arise.

Best team setup for Class I (EU) medical device QMS and technical documentation?

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