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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...

As per SAHPRA continuous interaction with stakeholders, Medical Device Unit would like to advise all stakeholders about the intention to host a workshop during the Month of April 2022 with regard to the following topic....