Groots Medical Device Expert & Groots In Vitro Diagnostic Expert
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Welcome to Groots Medical Device Expert, your trusted partner with over 15 years’ of experience in medical device Regulatory Affairs, ISO 13485 quality management systems (QMS), and EU MDR/IVDR compliance.
Do you want to be successfully navigated through complex regulations to bring safe, compliant products to market? We provide ISO 13485, IVDR, MDR, PRRC consulting, CE marking support, and FDA 510(k) guidance. Contact us today!
Contact our Senior Consultant for Expert advise
Recommendation Cooper Surgical
I would recommend Lizette to any medical device company who needs support for MDR compliance. She has always been on top of all tasks and was able to identify many areas for improvement by her incredible audit skills and insight for the quality management system. Her knowledge in the EU MDR regulation and compliance requirements is solid.
Recommendation Bilihome
Just recently Lizette has guided us through the 510(k) approach for our solution. Not only confirming our regulatory strategy, she even gave us concrete step-by-step approach towards an FDA approval. this helps us to plan time and money.
Bilihome can recommend Lizette de Groot for a first and thorough assessment of a regulatory pathway to the US.