MDSAP - Regulatory Globe https://www.regulatoryglobe.com Your Regulatory Partner for Medical Devices - EU MDR and IVDR Thu, 26 Sep 2024 10:11:08 +0000 en-US hourly 1 MDSAP vs. ISO 13485:2016 Checklist https://www.regulatoryglobe.com/shop/mdsap/checklist-mdsap/?utm_source=rss&utm_medium=rss&utm_campaign=checklist-mdsap https://www.regulatoryglobe.com/shop/mdsap/checklist-mdsap/#respond Tue, 09 Oct 2018 10:39:50 +0000 https://regulatory.wptheme.ch/?post_type=product&p=279 The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and helps to track those during the implementation phase. (Based on the MDSAP Companion document AU P0002.009 - 06. August 2024)

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This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

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

 

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The post MDSAP vs. ISO 13485:2016 Checklist first appeared on Regulatory Globe.

]]> Document Format:
  • Excel 2010
  • Excel 2013
  • Excel 2016

Language:

  • English

Reference Documents:

  • MDSAP Companion Document (FDA: AU P0002.009 from 06. August 2024)
  • ISO 13485:2016

The post MDSAP vs. ISO 13485:2016 Checklist first appeared on Regulatory Globe.

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