Medical Device – Institute for Medical Device Compliance & Regulations

7 Oct, 23

In the ISO 13485:2016 standard is written what should be

26 Sep, 23

This chapter of the standards explains how one medical device

10 Oct, 22

The ISO 13485 standard requires the medical device company to

29 Sep, 22

Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings,

24 Aug, 22

To have or not to have? To certify or not?