![]() Application to organizations throughout the life cycle and supply chain for medical devices.Increased linkage with regulatory requirements, particularly for regulatory documentation.Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements “Incorporation of risk-based approaches beyond product realization.According to the Regulatory Affairs Professional Society (RAPS), the largest differences between the 20 versions of the guidance include the following: Furthermore, ISO 13485:2016 draws particular attention to requirements regarding device usability and post-market surveillance.Īlthough the new document is simply a revision to the original guidance, there are a number of fairly significant differences between the two. The revised guidance highlights the importance of having a quality management system (QMS) in place throughout the supply chain. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.” ISO 13485:2003 vs. ![]() In addition, ISO has stated that the “requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
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