QMSPro Consulting

EU MDR FDA

QMSPro Consulting is the Copenhagen practice founded and led by quality and regulatory consultant Vlad Cintean. It supports medical device and regulated manufacturing organisations with quality-system implementation and remediation, audit preparation, CAPA, risk management and post-market compliance. Its work is aligned with EU MDR, FDA 21 CFR 820, ISO 13485 and MDSAP requirements, with direct hands-on support for client teams.

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Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago

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Notified body

MDC

1 review · updated over 2 years ago

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

Anonymous · 1 comment

8 months ago

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

Accepted 1 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