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Biocompatibility

The right materials build great products — and lasting consumer trust. At Chemva, we help you navigate the intersection of chemistry, biocompatibility, and regulatory requirements.
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About the 
Biocompatibility
Medical Devices
Drug Products
Combination Products
Personal Care Products
In the development of medical devices, combination products, drug packaging, and personal care items, ensuring biocompatibility is paramount.

At Chemva, we specialize in comprehensive biocompatibility evaluations, aligning with international standards such as:

  • ISO 10993, ISO 18562, ISO/TS 21726, ISO 14971, and additional standards for medical devices

For medical devices, our services, for example, encompass the preparing Biological Evaluation Plan (BEP) and Materials Risk Assessment (MRA), authoring Toxicological Risk Assessment (TRA), compiling Biological Evaluation Report (BER), designing implantation studies, and assessing degradation risks.

Medical Devices
Combination Products
Drug Products
Personal Care Products
Solutions
End-to-End Support for Safer, Smarter Medical Devices
Regulatory Consulting

In the dynamic realm of medical device innovation, aligning product development with diverse regulatory requirements is paramount.

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Regulatory Consulting
Regulatory Consulting

Our Regulatory Consulting services focuses on the areas of biocompatibility, chemical characterization, and materials science.

We understand that each market presents unique challenges and opportunities. Our approach involves a thorough analysis of your product's specific attributes, intended use, and target markets to develop a tailored biocompatibility strategy that aligns with your overall regulatory approach.

Our collaboration encompasses the entire product lifecycle, from initial concept through to post-market surveillance, ensuring compliance at every stage.​

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Our Approach

  • Regional Planning: Our recommendations for biocompatibility and chemical characterization consider global requirements. Depending on the market of interest, we provide guidance that enables efficient use of time and resources. We have experience supporting our clients for submission in USA, EU, UK, and Canada.
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Trust Figures
Transforming Material Challenges into Insights
90
+
Biocompatibility related projects such as BEP, BER, TRA, MRA
7
+
Projects assessing degradation products of resorbable and non-resorbable medical devices
17
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Projects establishing materials/biological equivalency for a medical device or drug packaging
CHEMVA
Proven Results
Real-World Insights From Complex Projects
Learn about our scientific approach that helps clients.
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