What are the key requirements for medical device regulatory? | |
Key requirements for medical device regulatory compliance include proper device classification, risk assessment, and adherence to quality management standards like ISO 13485. Manufacturers must conduct clinical evaluations, prepare technical documentation, and ensure labeling and packaging meet regulatory guidelines. Submissions such as FDA 510(k) or CE marking applications are necessary for market approval, followed by post-market surveillance and reporting. https://www.dueranconsultancy.com/medical-device-licenses | |
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