QLE Group

EU MDR IVDR FDA

QLE Group is a regulatory consultancy based in Brussels, Belgium. It supports medical device and health-technology companies with EU MDR and IVDR compliance, FDA pathways and CE-marking work. Its services include technical documentation, ISO 13485 quality systems, audits, post-market surveillance, PRRC support and EU authorised representation, delivered through a senior-led boutique model.

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Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software

10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel