Medical Device Material Compatibility Assessment
We examine the materials of test items at both the sample and finished product levels to evaluate their compatibility with the intended processes.
We’ve relied on Test Cert for multiple medical device testing projects, and they’ve never disappointed. Their team has deep knowledge of ISO 21530 and other relevant standards. Their timely, well-documented test reports helped us meet both local and international regulatory requirements with ease.”
– Dr. Ayesha Malik, Regulatory Affairs Manager, Meditech Solutions.
List Of Tests
Medical device material compatibility assessment services are available for various tests, including sprays tests, soak tests, contact tests, and wipe tests, based on standards such as EN ISO 21530 and BIFMA HCF 8.1-2017. Our testing capabilities cater to your needs, Monday to Friday, during business hours
What types of medical devices does TestCert test?
We provide testing services for a wide range of medical devices including diagnostic equipment, therapeutic devices, implantables, in-vitro diagnostics, and more. Our services cover both electrical and non-electrical medical devices.
What testing standards do you follow?
TestCert adheres to international testing standards such as ISO 13485, IEC 60601 series, ISO 14971 for risk management, and other relevant ISO and FDA guidelines to ensure device safety, performance, and regulatory compliance.
How long does testing usually take?
Testing timelines depend on the scope and complexity of the device and tests required. On average, testing takes between 2 to 8 weeks. We provide estimated timelines during the project planning phase.
What types of tests do you offer?
We offer a comprehensive suite of tests including:
Electrical safety and performance testing
Biocompatibility testing
Mechanical and durability testing
EMC (Electromagnetic Compatibility) testing
Chemical and toxicological testing
Sterilization validation
Packaging integrity tests
Do you assist with regulatory submissions?
Yes, TestCert offers consultancy to help you prepare technical documentation and test reports suitable for submission to regulatory authorities such as the FDA, CE marking bodies, and other international agencies.
Can TestCert test prototypes and pre-production devices?
Absolutely. We test both prototypes and production-ready devices to help you identify issues early and ensure compliance before mass production.
