Format & Content of a Medical Device File (MDF) - ISO 13485:2016, Clause 4.2.3
15:40
YouTubeMedical Device Academy
Format & Content of a Medical Device File (MDF) - ISO 13485:2016, Clause 4.2.3
This live-streaming video covered the format and content requirements for a medical device file (MDF). The requirement is found in ISO 13845:2016, Clause 4.2.3. However, we did not create a procedure for this until recently: https://medicaldeviceacademy.com/medical-device-file-procedure/ The reason is that the US FDA required a Device Master ...
1.2K viewsMar 1, 2024
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