Biocompatibility & Toxicology Services for Medical Devices

Our structured, transparent, and regulatory-focused Biological Evaluation Plan (BEP), Biological Evaluation Report (BER), and Toxicological Risk Assessment (TRA) process ensures your medical device achieves ISO 10993 compliance efficiently and with minimal risk.

Biological Evaluation Simplified

Phase I - Project Scoping
Estimated TAT: Based on Test

01 - Initial Meeting
Understand Device(s) and agree to scope of project.

02 - Client issues purchase order to Groenakker for project scope.

Phase II - Evaluation Details
Estimated TAT: Based on Test

03 - Client provides necessary information by filling out Groenakker Biocompatibility Request Form.

Phase III - Evaluation Drafting and Revision
Estimated TAT: 2 Weeks for Initial Draft

04 - Groenakker will draft a comprehensive initial BEP to minimize regulatory risk.

05 - We provide up to 3 revisions to meet the risk tolerance of each individual client.

Phase IV - Final Approval
Estimated TAT: 1 Week

06 - Final approved BEP delivered to client. Ready to execute testing (as necessary).

Comprehensive Evaluation

With a constantly changing compendium of standards and guidance documents, it can be daunting to know where to start and how to adequately document the biocompatibility of your device. With risk analyses providing a firm foundation - we clearly document each step of the biocompatibility assessment process to provide clarity to decisions made and ensure our client's put their best foot forward in regulatory reviews.

Our goal is to provide our clients with a clear pathway toward providing evidence supporting the biocompatibility of their devices. Whether through documentation of the assessment, management of testing, or simply by providing a clear road map for success - we eat, sleep, and breathe biocompatibility.

Laboratory Excellence

State-of-the-art testing facilities for comprehensive biocompatibility assessments.

Medical Device Testing

Rigorous testing protocols ensuring device safety and regulatory compliance.

Research & Development

Innovative approaches to biological evaluation and risk assessment.

Quality Assurance

Meticulous documentation and validation processes for regulatory submissions.

Regulatory Compliance

Expert guidance through FDA, ISO 10993, and other regulatory requirements.

Comprehensive Testing

Full spectrum of biocompatibility testing from cytotoxicity to implantation studies.

Groenakker works closely with our clients to create bespoke biological safety evaluations. Whatever biocompatibility needs you have, we have the solution and expertise to drive success.