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
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.