Biocompatibility and how to apply extractables and leachables to medical devices. ISO 10993 now requires knowledge of any chemicals released by a device while it is in use. This is now included in the testing matrix for each device category. Although materials characterisation isn’t the only way to get this information, it’s the most likely way to discover unexpected materials.
Risk management in the medtech industry extends beyond product development and manufacturing to become an integral part of your product’s life cycle. Clin-r+ looks at how ISO 14971:2019 specifies the international requirements for medical device risk management systems, as well as best practices for the device’s entire life cycle.
Labels for medical devices are indispensable. Clin-r+ are here to help you understand labels, the MDR requirements, and how to put them into action on your systems.
A Clinical Evaluation Assessment Report is required for all manufacturers who want to sell medical devices in the European Union. CEAR demonstrates that your product accomplishes its intended purpose without endangering users or patients, and the manufacturer’s reputation or financial prospects.
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