#Iso 13485 changes iso
Sénac will talk about the new requirements introduced by the European IVD Regulation with respect to the Quality Management System to the In Vitro Diagnostic (IVD) legal manufacturers, as well as, the major changes of ISO 13485:2016 and how, the requirements and changes for both the IVD regulation and ISO 13485:2016, interact and complement each other. Julien Sénac for a discussion on the In Vitro Diagnostic (IVD) European Regulation: its impacts on the compliance with ISO 13485:2016. More emphasis is put on results of activities and effectiveness of quality systems and measurable quality objectives.
Julien Sénac for a discussion on the In Vitro Diagnostic (IVD) European Regulation: its impacts on the compliance with ISO 13485:2016. ISO 13485:2016 clarifies top management responsibilities, laying out explicit requirements for reviews at documented, planned intervals. However, with the publication on May 25th, 2017 of the new EU In Vitro Diagnostic (IVD) Regulation, a reassessment of this plan is needed to integrate the specific QMS requirements linked to this new regulation. For In Vitro Medical Device Manufacturers, an evaluation of their processes and their overall QMS with regard to ISO 13485:2016 is essential: through a gap analysis and the design of an action plan, In Vitro Medical Device Manufacturers have started to establish the foundation to successfully transition to ISO 13485: 2016. Medical Device Manufacturers went through significant changes in the last couple of years: The publication of ISO 13485:2016 on February 25th, 2016 introduced a new level of expectations in regard to their QMS compliance. 4.1.4 a-c: Changes to QMS processes shall be evaluated for their impact on the QMS, evaluated for their impact on the medical devices and controlled in accordance with ISO 13485 and regulatory requirements.
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