Within medical devices, biocompatibility assessments are essential in the early stages of development to ensure patient safety. Notified Bodies must see adequate data on biocompatibility to be sure the device is fit for purpose. This course will provide you with a solid understanding of the principles behind crucial regulations and issues within biocompatibility.
Supported by a wealth of examples and two practical sessions, this course will give you an in-depth look at ISO 10993. Over two days, you will examine the biological evaluation process and will improve your understanding of testing end-points and testing alternatives. Delegates will also be provided with additional time to discuss the implications of Brexit.
Hans gained his doctorate in Microbiology from the University of Hamburg. He went on to become Head of Microbiology for Madaus AG in Cologne. Following this, he became a quality manager with Becton & Dickinson Diagnostics, Germany and then acted as a lead auditor for the notified bodies TUV Rheinland and TUV Sud. His duties included the assessment of technical files especially biocompatibility, microbiology and sterilization. Hans now runs his own training and consultancy business, specialising in delivering courses and advising clients on biological safety, risk management, audits and a range of other topics in the medical device/IVD arena.
This course will be useful for anyone new to biocompatibility for medical devices, or who would like a refresher of this material, including:
I enjoyed getting a better understanding of the requirements through the workshop!
The course provided full knowledge on the topic, also covered all of ISO 10993 and international aspects.