Groots Medical Device Expert & Groots In Vitro Diagnostic Expert
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Do you need any support with ISO 13485, MDR 2017/745 or IVDR 2017/746? Are your looking for a Person Reponsible for Regulatory Compliance (PRRC)?
Lizette de Groot is the allround senior consultant who can help you with all aspects of medical devices and in vitro medical devices in the field of quality assurance and regulatory affairs.
Contact our senior consultant Lizette
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.