SCOPE 

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Devices
In Vitro Diagnostics (IVDs)
Companion Diagnostics (CDx)
Laboratory Developed Tests (LDTs)
In-house IVDs
Regulations
IVDR 2017/746
DIR 98/79/CE
21CFR
Therapeutic Goods (Medical Devices) Regulations 2002
Standards
ISO 13485
ISO 14971
ISO 20916
ISO 23640
ISO 62366
CLSI guidelines

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