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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.

STEP 1: DEVICE CONTACT TYPE(S) & DURATION(S) CHARACTERIZATION

A critical key to success in any biological evaluation is understanding the nature of the device's intended use and proper contact type & duration characterization. This includes evaluation of how a device may contact patients as well as the surgical staff operating it.

STEP 2: MATERIAL & MANUFACTURING PROCESS DEFINITION

Key to understanding biological hazards of a given device is understanding all materials of construction, including additives, coatings, and pigments, as well as manufacturing steps/environments utilized in production.

STEP 3: LITERATURE SEARCH

Before assessing the device for biological hazards, a thorough literature search is carried out on each of the patient-contacting materials. The literature search not only reviews published research for a specific material, but also evaluates its suitability for the intended application.

STEP 4: BIOLOGICAL HAZARD EVALUATION

With the use case of a device, its materials of construction, and manufacturing processes well-defined and thoroughly researched, it is then possible to identify potential biological safety hazards. Using ISO 14971:2019 approaches, the biological safety risk assessment outlines potential hazards, existing mitigations, and future strategies.

STEP 5: GAP ASSESSMENT & TEST PLANNING

Testing is not always required. Based on the information gathered, a gap assessment is conducted and a test plan is generated, if appropriate. Our goal is to maximize evidence of safety while minimizing cost and turnaround time.

STEP 6: REPORTING CONCLUSIONS

With characterization, evaluation, and testing completed, the final step is to analyze all biocompatibility data and generate safety-based conclusions for the product under evaluation.

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.

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