An NSF International Company M2 - Design, Risk and Safety Standards - Understanding Standards for CE Marking of Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 2
£735.00 excl VAT
About this course
Standards are the life-blood of the European Medical Device CE Marking framework. As a quality, regulatory, development or other related professional within medical devices you will need to ensure that you are aware of the development, implementation, adoption and updates associated to standards and how manufacturers should react upon the adoption and introduction of these standards as harmonized standards within Europe. The course takes you through the general lifecycle of medical device related standards and introduces IMDRF guidance, TR16142 and the links between the medical device directive essential requirements and harmonized standards. Furthermore we examine the relationship between Risk and Standards as defined within ISO Guide 63:2012. From this foundation we then take you through the fundamental requirements and expectations of how a manufacturer adopts these standards either in full or ‘partially’, explaining how to plan for this within the design, technical data and post market change activities within your quality management system.
Who Should Attend
Professionals with a responsibility for demonstrating through standards that a medical technology product is safe and performs within the CE marking requirements.
