Biocompatibility Testing for Medical Devices

Why Biocompatibility Matters for Your Medical Device

An essential part of the development of health care products is conducting an adequate biocompatibility evaluation of the product. Whether your product is an implantable medical device, a single use item like a surgical tool, an indirect patient contacting system like a blood transfusion system, or a container for a drug product, conducting biocompatibility for medical devices is critical for determining device safety and complying with FDA guidance.  

Cambridge Polymer Group: Your Partner in Biocompatibility

Many medical products and their component materials are made from polymeric materials. Cambridge Polymer Group’s experience with polymers helps guide the appropriate consideration of additives, manufacturing processes, and degradation products that may influence the biocompatibility of a product.

Our scientists stay updated on new regulations for device biocompatibility assessment and are experts in evaluating products for biocompatibility risk. They lead discussions on best practices in analytical evaluation. We help clients with FDA interactions during Q-subs and deficiency responses. 

Our ISO 17025-accredited laboratory is experienced in evaluating biological safety of materials for new devices, proposed process changes in existing devices, and unexpected outcomes from biological endpoint tests. We design the appropriate battery of tests to fulfill biocompatibility testing requirements, using risk based approaches. We offer extractables and leachables test services on short duration and long duration medical devices for chemical characterization. 

Save Time, Money, and Minimize Compliance Risks with Our Polymer Scientists

Cambridge Polymer Group subject matter experts offer the following biocompatibility services: 

• Biological Evaluation Plan/Biological Evaluation Report (BEP/BER): We guide you through creating these essential documents, as mandated by ISO 10993-1 and ISO 14971 for risk management.
• Biological Risk Evaluation with Gap Assessment: We identify potential biocompatibility risks and any gaps in your testing plan. 
• Material Selection for New Medical Products: We help you choose the right polymers for your device, considering biocompatibility alongside other critical factors.
• Extractables/Leachables Testing & Chemical Characterization: We perform these tests according to ISO 10993-18, providing valuable insights into potential interactions between your device and the body.
• Risk Assessment for Material or Process Changes: Evaluating the impact of any material or manufacturing changes ensures continued biocompatibility.
• Shelf Life & In Vivo Life Assessment: We help you determine how long your device remains safe and functional, both in storage and within the body.
• Sterilization Modality Selection: We guide you in choosing the most effective and biocompatible sterilization method for your device.

Contact us for a quote, or call us at 617-629-4400.