Biological Evaluation
Expert ISO 10993-1:2025 product review and documentation of biological evaluation plans and reports. Biocompatibility made easy.
LEARN MOREBIOCOMPATIBILITY & TOXICOLOGY SOLVED
GROENAKKER PROVIDES CONCIERGE-LEVEL ADVISORY AND TEST SUBCONTRACTING SERVICES AT INDUSTRY-LEADING TURNAROUND TIMES.
INSTANT ESTIMATEInnovation 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.
Leachables & Extractables
Streamlined and cost-contained solution for leachables/extractables and toxicological risk evaluation. Tailor-made to meet FDA and EU MDR efficiently.
LEARN MORE
Test Subcontracting
Concierge-level sourcing and coordination of biocompatibility testing with the world's leading laboratory service providers. Global reach – local management.
LEARN MORE
Additional Services
Concierge-level services for which our team routinely provides expert support to our clients.
LEARN MORE
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 forging relationships with our clients. Our aim in all things is to develop lasting relationships that continually provide value-added solutions.
Your challenges are our challenges.
Your problems are our problems.
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 with thoroughness and attention to detail, ensuring your success with every project. Our aim in all things is to develop lasting relationships that continually provide value-added solutions.
LATEST NEWS
The Concierge Is In
8/19/2025Far from the neglected hotel desk often bypassed for TripAdvisor, Groenakker reimagines “concierge” as its Latin root conservus—a co-servant partnering with clients to navigate the complexities of....
READ MORE
Press Release
7/11/2025Philadelphia-based Groenakker LLC earned ISO 13485:2016 accreditation, affirming its excellence in providing With offices in Philadelphia, PA, and Chennai, India, Groenakker’s certified quality manage...
READ MORE
The Particulate Predicament
6/16/2025Explore the complexities of particulate investigations, emphasizing the challenges faced by manufacturers when defining and controlling particulate limits. A two-fold approach is proposed, focusing on...
READ MORE
INTEGRATE
CREATE
EXECUTE