When preparing for the transition from IVDD into IVDR there are several activities to manage, like updating or creating Technical Documentation and adapting the Quality Management System, which in addition, need to be supported by robust processes for Risk Management and Post-Market Surveillance.
While planning for this you may struggle with questions like; How do I set the scope and objectives for the Performance Evaluation? How do I perform risk analysis, and estimate probability & severity? How do I evidence fulfilment of the ‘General Safety and Performance Requirements? What is the responsibility of the PRRC? What will the NB need look for when auditing our Quality Management System? How to deal with Class A or legacy devices? This training will give you the answers!
After this 2-day training you will be better equipped to tackle the questions above. We’ll walk you through the key IVDR requirements on your Technical Documentation and provide you with tools to perform a gap analysis of and update of your quality management system, to ensure compliance with the IVDR. The relationship between IVDR, ISO13485:2016 and other standards such as ISO14971 as well as role & responsibilities of the PRRC will be clarified.
Completion of this course will give you the knowledge needed to:
Quality Managers, the PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer. Quality Specialists/ Engineers, RA Managers/Specialists, Persons involved in Design & Development, writing or maintaining Technical Documentation, such as: Design and development engineers, Quality representatives in design and development projects, or the Head of R&D.
Note. To register for a public course/event – Use the button “ADD TO CART” above.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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