Medical Device Regulatory & Biocompatibility Experts

Medical device regulatory consulting, biocompatibility and toxicology services, and FDA & EU MDR support delivered with concierge-level advisory and industry-leading turnaround times.

Innovation Accelerated

Our end-to-end medical device regulatory services, ISO 10993 consulting, and global biocompatibility and toxicology support help you streamline FDA and EU MDR submissions with confidence.

Biological Evaluation & Biocompatibility

Medical device biocompatibility services including ISO 10993-1 biological evaluation, BEP / BER documentation, and risk-based toxicological assessment.

Leachables & Extractables

Streamlined and cost-contained solution for leachables/extractables and toxicological risk evaluation. Tailor-made to meet FDA and EU MDR efficiently.

Test Subcontracting

Concierge-level sourcing and coordination of biocompatibility testing with the world's leading laboratory service providers. Global reach – local management.

Additional Services

Concierge-level services for which our team routinely provides expert support to our clients.

We Are
Groenakker

What's in a name? Everything.

Groenakker is of Dutch origin and carries a meaning which embodies limitless potential, endless possibility, and unlimited opportunity. Literally meaning “Green Field“, the name represents our commitment to creative solutioning and cultivation of lasting relationships with our clients. Our aim in all things is to develop lasting relationships that continually provide value-added solutions.

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Your challenges are our challenges.
Your problems are our problems.

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Strategic Relationships

With ISO 13485:2016 accreditation of our Quality Management System, Groenakker's advisory and test subcontracting services meet the highest medical device standards. We deliver precise, compliant solutions fast— elevating your success with quality you can trust. Managing complex scientific problems has never been so easy.