An NSF International Company M2 - Design, Risk and Safety Standards - Understanding Design Control for Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 2
£735.00 excl VAT
About this course
From a recent review of FDA warning letters, EU notified body assessments and the specific introduction of combination product regulations, it is clear that the concepts and techniques used in design control and risk management are still unclear to manufacturers wishing to implement, improve and maintain their development processes. We take you through the requirements for combination product design and development processes subjected to CFR21 Part 4 and the typical requirements defined in CFR21 Part 820.30, ISO 13485 and the European Medical Devices Directives. Once understood, we provide you with typical solutions to implement within your development processes, not least how to retrospectively address design of combination product device elements.
Who Should Attend
Development, regulatory and quality professionals responsible for design control and design transfer of medical devices. This course demonstrates your expertize to coordinate, plan and control the necessary elements of design quality to produce a safe and effective medical device. Pharmaceutical quality professionals responsible for development of combination products will benefit from completing this course as it covers all aspects of the design control and design transfer requirements within CFR21 Part 4.
