ISO 13485:

• It pertains to medical devices & related services for regulatory requirements.
• Sterilization (Gas, Steam, IR radiation) & its validation play a very important & crucial role.
• Electro medical devices need EMC / Electrical safety compliance.

3 categories of medical device:

•  Global Harmonized task force (GHTF) working with regulatory markets such as EU (CE Mark), USFDA & other developed countries.