MCRA has extensive experience successfully navigating regulatory biocompatibility expectations for complex medical devices.
What is Biocompatibility?
Biocompatibility is the rigorous scientific approach to ensuring that a medical device is compatible with the human body, preventing harm or adverse reactions in clinical use. Evaluating biocompatibility involves a comprehensive risk management process, assessing multiple device aspects from a biocompatibility standpoint. This includes examining materials, manufacturing processes, intended clinical use, and associated risks such as chemical toxicity or adverse biological responses. The goal is to minimize unnecessary testing while identifying and mitigating risks to ensure compatibility and balance benefits and risks for patients.
Your Biocompatibility Expert
MCRA specializes in comprehensive services to ensure your medical devices are biocompatible, empowering you to confidently bring safe and effective products to market. Our tailored approach considers the unique aspects of each medical device, conducting a thorough risk assessment that covers the entire lifecycle of your device. With a team of experienced professionals with past work experience in both Industry, FDA and European Notified Bodies, we are well-versed in global biocompatibility requirements, evaluation of materials, manufacturing processes, clinical use, and potential risks related to biological safety of medical devices.
MCRA’s streamlined biocompatibility process saves time and strengthens your market position. We provide expertise on regulations, strategy development, compliance with standards, testing design, and toxicological risk assessments. We collaborate closely with you to develop a customized plan for biocompatibility testing, addressing knowledge gaps and providing a clear path to success. Our biocompatibility expertise empowers you to make informed decisions, mitigate risks, and efficiently achieve regulatory compliance.
Let MCRA guide you through the complex world of biocompatibility, ensuring your medical devices are safe and life-changing.
Global Biocompatibility Services Offered:
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Expertise on global biocompatibility regulations
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Regulatory support in response to deficiencies from global regulators
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Biocompatibility strategy development for new devices, combination products, device changes, material supplier changes
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EU-MDR and FDA compliant biological evaluation plans (BEP) and biological evaluation reports (BER)
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Gap assessments to the ISO 10993 series of standards and global biological safety standards
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Design of biological testing, test protocol and test report review
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Device materials selection, test article preparation, management testing activities
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Chemical Characterization (Extractables & Leachables) testing design
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Toxicological risk assessments (TRA)
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Materials, device and processing changes
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Viral inactivation validation (ISO 22442)
Contact A Biocompatibility Expert
