LIVE VIRTUAL TRAININGS
Learn in small groups from top experts and real-life examples

Expert Advice Community

Guest

MVP

  Quote
Guest
Guest user Created:   Jan 06, 2022 Last commented:   Jan 10, 2022

MVP

Hello,Thanks for your quick response.our commercial team produce a medical device as a startup business and we are in the MVP stage.I would like to ask you that is it necessary Iso13485 for it? So, if  "yes" how can we should apply?With thanks
0 0

Assign topic to the user

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 Jan 10, 2022

According to the MDR, Article 8 - Use of harmonized standards, it is the manufacturer's obligation to prepare and manufacture their medical device according to the harmonized standards published in the Official Journal of the European Union. On that list is more than 300 different standards considering how the certain medical device must be prepared, The only standard that is on that list considering the quality management system is ISO 13485:2016. Therefore, ISO 13485 is necessary to be implemented.   

For more information, see: 
EU MDR Article 8 – Use of harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standa

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jan 06, 2022

Jan 10, 2022