MDSAP ISO 13485 2016


This multipurpose resource has built-in functionality to assess quality system requirements of the ISO 13485:2016 standard alongside the specific requirements of each auditing organization participating in MDSAP, allowing medical device companies to identify gaps within their QMS processes and track subsequent changes throughout implementation.



    Features & Benefits

   Helpful overview between the gaps and your processes
   Shows "risk grading" of each MDSAP requirement
   Inclusive status tracking during the implementation phase
   Easy to sort by regulatory authority in MDSAP
   Reusable tool to prepare for MDSAP audits
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United States of America

Food and Drugs Administration (FDA)

Quality management requirements are based on 21 CFR Part 820.



Agência Nacional de Vigilância Sanitária (ANVISA)

Quality management requirements are based on RDC ANVISA 16/2013


Ministry of Health Labor and Welfare & Pharmaceuticals and Medical Devices Agency (MHLW & PMDA)

Quality management requirements are based on MHLW Ordinance No. 169



Health Canada

Quality management requirements are based on ISO 13485:2016.

Australia flag


Therapeutic Goods Administration (TGA)

Quality management requirements are based on TGA regulation (TG(MD)R Sch3).



ISO 13485:2016

Gap Assessment Tool

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ABOUT Regulatory Globe

To develop medical products that improve quality of life and extend life expectancy is the goal of the medical device industry. In order to serve this basic need optimally, laws and regulations are inevitable. Such regulations ensure safety and quality of products as well as raise the state of the art and thus promote progress steadily. This is the reason why it is so important to take the new requirements as an opportunity for improvements and not as a burden. Only companies that recognize this will be successful in the long term.

This is where the task of Regulatory Globe begins. Together with our partners, we specialize in monitoring laws and regulations and provide tools that help our clients improve their products processes. This will eventually benefit the people in need of these medical devices. Visit our website to learn more by clicking here.