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Inquiry for missed document

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Guest user Created:   Mar 09, 2022 Last commented:   Mar 09, 2022

Inquiry for missed document

My company was recently adopting your ISO 13485 system. Could you please check if the documents we get from you complied with MDSAP with the USA, Canada, Japan, Brazil, Australia and Europe (MDR) involved?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Mar 09, 2022

Our ISO 13485 Documentation toolkit is in compliance with all requirements from ISO 13485. FDA revealed plans to harmonize its CFR 21 with ISO 13485 in 2018. Due to the Corona pandemic, this process has been a little bit delayed, but it is expected to be solved soon.

For more information see this link: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0910-AH99

Considering the EU MDR 2017/745; there are some more documented requirements for QMS (stated in Article 10) as part of our ISO 13485 & MDR toolkit.

For more detail on this topic, please see following article:

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