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No, only medical devices that touch or enter the body usually need biocompatibility testing. Things like implants or skin-contact items get tested, but devices that don’t directly contact people, such as software, usually don’t.

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Melinda Parker

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5mo ago

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To find the right biocompatibility services for medical devices, consider the following steps: Determine your specific needs: Consider the type of medical device you are developing, its intended use, and the regulatory requirements for biocompatibility testing. Research biocompatibility service providers: Look for companies that specialize in biocompatibility testing for medical devices and have experience in your specific area of need. Check for accreditations and certifications: Ensure the service provider is accredited by relevant bodies such as ISO 17025 or FDA-recognized. Evaluate their services and capabilities: Ensure the service provider offers the type of testing you need, has the necessary equipment and facilities, and has a good track record in the industry. Compare costs and turnaround times: Get quotes from multiple service providers and compare their prices, as well as their estimated turnaround times. Consider the level of customer service: Look for a service provider that offers good customer support, including clear communication and prompt responses to inquiries. Make an informed decision: Based on your research and evaluation, select a biocompatibility service provider that meets your needs, budget, and timeline.


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