An NSF International Company M9 - Biological Evaluation & Test Methods- Undertaking Biological Evaluation for CE Marking Step by Step (QP)
PrintPart of Medical Devices QP Training Module 9
£1470.00 excl VAT
About this course
Understand the implications of the regulatory developments in Europe and the proposed revision of the FDA Blue Book 510(k) Guidance in the Biological Evaluation of Medical Devices. The ISO 10993 series of standards, covering biological evaluation of medical devices, is well established and regulatory authorities worldwide require compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. The development of a European Regulation for Medical Devices is ongoing and significant changes are known or expected. New parts in the ISO 10993 series are being developed, e.g. ISO TS 10993-22, Guidance on Nanomaterials, and many existing parts are being revised. The key ISO 10993- :2009 is now up for 5 year systematic review and some revision is likely. This interactive seminar will provide opportunities for discussion, to have your questions answered, and realistic group exercises on these standards.
Who Should Attend
This course is essential for any professionals responsible for product safety within medical devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill.
