Biocompatibility & Toxicology Solved

Groenakker provides concierge-level advisory and test subcontracting services at industry-leading turnaround times.

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Regulatory Support & Compliance

Expert guidance to navigate global regulatory requirements quickly and effectively.

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Material Selection Assistance

Get the right materials and solutions for medical devices with proven performance.

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Testing & Certifications

Accelerate your product's time to market with world-class testing and certification support.

Innovation Accelerated

Our scientific advisory services provide clients with the concierge-level support necessary to streamline product registrations. We pride ourselves in focusing on the development of high-quality services & deployment of industry-leading solutions to meet our client's unique needs.

Biological Evaluation

Expert ISO 10993-1:2018 product review and documentation of biological evaluation plans and reports. Biocompatibility made easy.

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.