Chemva | Biocompatibility Consulting Logo - medical devices

Chemva | Biocompatibility Consulting

medical devices
China's Best One-Stop Medical Equipment Provider
About

Chemva is your trusted and leading partner in the field of materials science and chemistry, biocompatibility, and toxicology for medical devices. With an in-depth understanding of the ISO 10993 and ISO 15862 series and global requirements and variations among regulating agencies, we remain constantly informed about the latest updates and regulatory changes in terms of materials for medical devices. Our expertise extends to consulting you with materials selection and designing experiments to predict performance and potential failures for various materials (i.e. polymers, metals), providing biocompatibility and toxicology consulting (i.e. writing toxicological risk assessments), and training services with a global outlook, encompassing compliance with EU MDR and the US market. Biological assessment plays a crucial role in the developmental journey of medical devices. To help you meet stringent requirements in a regulatory-compliant manner and achieve market access within your specified timeline, we offer extensive Biological Evaluation Plans and Reports, along with Toxicological Risk Assessments. We also provide opportunities for both internal and external education in the areas of Polymers & Coatings, Chemistry from a medical tech perspective, Materials Performance & DOEs, Failure Analysis, and Biocompatibility & Toxicology for medical devices. To learn more, reach out to us at [email protected] or visit our website at www.chemva.com.

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Keywords
biocompatibility iso 10993 iso 14971 fda guidance document mdr rohs echa toxicological risk assessment medical devices consultancy toxicology materials science polymers coatings coatings for medical devices design of experiments biological evaluation plans chemical characterization medical equipment manufacturing raw material quality check tissue compatibility regulatory support extractable & leachable studies leachables and extractables material risk assessment risk management iso 10993-18 analytical methods toxicological data custom testing protocols biological evaluation material performance prediction
Company Information
  • Employees 2
  • Founded 2023
Location

Cleveland, Ohio, United States

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