Medical devices Management Systems ( ISO 13485 )
Comprehensive Management System for the design and manufacture of medical devices and related services for regulatory requirement.
Sterilization ( Gas, Steam, IR Radiation ) and its validation play a very important and crucial role.
Electro Medical devices need EMC/ Electricity Safety Compliance.
Three Categories of Medical Devices : General/Active Implantable/Invitro Diagnostic Devices.
Global Harmonized task Force Task Force ( GHTF ) working with regulatory markets such as EU ( CE Mark ), USFDA and other developed countries.
This standard superseded earlier standards such as ISO 46001 and ISO 46002.