The United States General Services Administration has recently announced that the FDA will update the existing Quality System Regulation for medical devices with the requirements of ISO 13485:2016: View publication.

This update will harmonize and modernize existing FDA requirements. It will enable manufacturers to cover the QMS requirements of the FDA using this international standard, which is well known in the sector. The timeline of this update has not yet been published. 

EN ISO 13485:2016 is a harmonized standard under Medical Device Regulation (EU) 2017/745. 

Our Notified Body SGS Fimko Oy offers ISO13485 certification also for the companies that are just beginning their journey to achieving MDR compliance.  

You are welcome to contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. to learn about our services. We will explain SGS’s MDR certification process to you and answer your questions.  

We can offer you support at short notice, meaning you can start the certification process promptly. 

Your contact 

Armin Hudetz 
t: +49 89 7874 75-133 
f: +49 89 1250 4064-133 
email: This email address is being protected from spambots. You need JavaScript enabled to view it. 
 
Customer Service Team 
t: +49 89 7874 75-222 
f: +49 89 1250 4064-100 
email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

Links 

Publication of United States General Services Administration
Information about our certification service
Notification Scope of SGS FIMKO Oy
SGS Fimko Ltd NB 0598 Standard fees list for MDR (EU) 2017/745 EC Certification