ADDITIONAL SERVICES

Every story has a beginning, sterilization is at the center of ours. While time has brought diversification in experience and expertise, sterilization is where it all began. With decades of hands-on experience validating sterilization processes & supporting ground-up facility builds, we're confident we can support any of our client's needs. Key areas of expertise include:

The EU Medical Device Regulation (MDR) has put a tremendous emphasis on clinical performance and benefit of new medical products along with maintenance of detailed post-market surveillance (PMS) data. The more general, lenient, & ‘once-and-done’ approach of clinical evaluations associated with the Medical Device Directive (MDD) are a thing of the past for companies that are transitioning to the MDR (or hope to in the future). Documenting the clinical performance of your product and the benefit which it provides to the patient is key to any successful European registration under the MDR. Groenakker has a team of clinical professionals that are dedicated to meeting our clients' unique needs in performing clinical evaluations. Whether you are in need of a single clinical evaluation for a product, or need help establishing systems to support ongoing clinical evaluations and clinical data gathering — Groenakker has the expertise to provide bespoke support.

Our team of Clinicians, PhD Researchers, and Biomedical Engineers provides comprehensive support to all Clinical Evaluation needs.