Our Services
BIological evaluation plans
The Biological Evaluation Plan is essential to ensuring a Medical Device, along with its manufacturing processes, are evaluated against the applicable standards for a successful overall biocompatibility evaluation. We offer extensive experience in drafting these evaluations in compliance with ISO 10993-1, assisting in complicated biocompatibility preparation designs and ensuring all biological endpoints are either appropriately assessed or tested to standards to ensure first pass success.
Midwest Biocompatibility Consultants have numerous years of experience in the Chemical Characterization process, which when designed appropriately in collaboration with an associated Toxicological Risk Assessment, can be leveraged to risk assess long-term tests including genotoxicity, systemic toxicity and carcinogenicity; ultimately saving you time and money.
Biocompatibility evaluation reports
Midwest Biocompatibility Consultants offer full spectrum biocompatibility support to our clients. Following the execution of biocompatibility testing, in alignment with a Biological Evaluation Plan, we will review all final biocompatibility reports conducted by CROs to ensure accuracy and alignment with study protocols, evaluate each biological end point data as part of the overall biocompatibility evaluation and generate a final Biological Evaluation Report that demonstrates a medical device's acceptable biocompatibility profile in alignment with ISO 10993-1 and regulatory body requirements/expectations.
toxicological risk assessment in alignment with iso 10993-17
Midwest Biocompatibility Consultants have authored numerous Toxicological Risk Assessments for submissions to regulatory agencies. Our knowledge and direct experience in both the ISO 10993-18 analytical laboratory as well as the ISO 10993-17 Toxicological Risk Assessment offers a unique combination that provides synergies between the two skill sets. As such, Midwest Biocompatibility Consultants can review, discuss, understand and leverage extractable and leachable chemical characterization data which further supports in-depth and thorough Toxicological Risk Assessments.
Material/process change impact assessments
With the status of the supply chain throughout the medical device industry, Midwest Biocompatibility Consultants are there to help address and evaluate these manufacturing changes as they arise. Whether through a full Biological Evaluation Plan or individualized technical memorandums, we're here to help your organization navigate these industry challenges.
Gap & equivalency assessments
Looking to leverage previously generated biocompatibility or chemical data? Midwest Biocompatibility Consultants has assisted in navigating this useful, burden lowering option to help accelerate client's timelines.
Regulatory material assessments
Midwest Biocompatibility Consultants can assist you in performing assessments of materials that require regulatory declaration including PROP65, EU REACH/RoHS, EU MDR, and EU Persistent Organic Pollutants.