how their execution will impact the
organization in consideration of regulatory requirements before they are
finalized and executed. Product and
process data review are required. Overall, the CAPA must link to product risk
The evolution of ISO 13485:2016 is
coming at a pivotal time. Manufacturers
and accreditation and certification bodies will have three years to transition to
the revised standard.
The revised standard places greater
importance on QMS throughout the supply
chain and product lifecycle. Risk and opportunity analysis along the product development lifecycle, from design to supply chain
to distribution, are at the core, producing safe
and effective medical devices. A properly
executed QMS system will go a long way
13485:2016 and reducing risk. MDT
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