Medical Device Challenges
Today's medical device industry is very challenging, as the range of products and the organizations that manufacture and market them is incredibly diverse.
Medical devices can include everything from tongue depressors, toothbrushes, sunglasses, scalpels, contact lenses, diagnostic test systems, Magnetic Resonance Imaging (M.R.I.) systems, medical lasers, drug-eluting stents, pacemakers, and mobile apps.
The ISO 13485 standard may be applied to all of them and even to the suppliers of medical device components.
This, in part, is the reason trying to standardize systems consistently across organizations is such a challenge.