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Modatory Records Required for ISO 13485 : 2016 Complaince
Modatory Records Required for ISO 13485 : 2016 Complaince
Reference ISO : 13585:2016
List of Records Required for the complaince of MD-QMS Standards ISO 13485: 2016
S. No. | Reference Clause ( ISO 13485:2016) | Record’s Title |
1. | 4.1.1 | Establish and Maintain records needed to demonstrate conformance to this International Standard |
2. | 4.1.6 | Records of the Computer software validation |
3. | 5.6.1 | Records from Management Review |
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