The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase.
The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase. (Based on the MDSAP Companion document / FDA).
Benefits:
- Simple overview / No paper chaos
- Easy to sort by specific county requirements
- The checklist supports well during the implementation
- Helpful overview during the next MDSAP audit
What you get:
- Instruction for use
- Technical Support
- Customer feedback improved tool
For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced...
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