ISO 13485 Conformity Assessment Body Communication

To achieve certification to the ISO13485 standard for medical devices, the certification process requires each medical device establishment to implement a formal QMS which must be inspected and certified by an independent conformity assessment body (CAB) which has in turn been accredited by The South African National Accreditation System (SANAS) and recognised by South African Health Products Regulatory Authority (SAHPRA). The documents provide guidance to conformity assessment bodies . SAHPRA and SANAS have engaged to refine the process .

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2022 Aug