ISO 13485:2016 - Medical Devices Quality Management Systems
Main Technical Area as per IAF MD 8
Description
Technical Areas
A 1.1
Non-Active Medical Devices
General non-active, nonimplantable medical devices
Devices for wound care Non-active dental devices and accessories
Non-active medical devices other than specified above
A 1.2
Active Medical Devices (Non-Implantable)
General active medical devices Monitoring devices
Active (non-implantable) medical devices other than specified above
A 1.4
In Vitro Diagnostic Medical Devices (IVD)
Reagents and reagent products, calibrators and control materials for:
Clinical Chemistry
Immunochemistry (Immunology)
Haematology / Haemostasis / Immunohematology
Microbiology
Infectious Immunology
Histology/Cytology
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A 1.7
Parts or services
Distribution services (Distributors providing storage and delivery of Medical Devices, not acting as a ‘legal manufacturer’ for Medical Devices.)
