510(k) Tip -14 Different things you need in a medical device testing report
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YouTubeMedical Device Academy
510(k) Tip -14 Different things you need in a medical device testing report
The 14 requirements for a non-clinical benchtop testing report are listed below: 1. test performed 2. objective of the test 3. method, procedures, and standards 4. sample info with lot information 5. statistical sampling 6. selection of worst-case samples 7. step-by-step protocol - include pictures of the testing and equipment 8. predefined ...
872 views2 months ago
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