Biocompatibility assessments are an essential part of submissions to regulatory agencies for medical devices. 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:
With ISO 10993 guidance fast evolving amidst global regulatory change, the industry have many questions on best practices for biocompatibility testing and evaluations.
Join TC/194 Working Group, Notified Body and industry speakers this October in Chicago at Biocompatibility for Medical Devices US as they provide insights, case studies and guidance to help you overcome the challenges with ISO 10993, the risk-based approach, chemical characaterization, toxicological risk assessment and regulatory impact and implementation.
Download the full agenda to find out more.
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.