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Understanding Biocompatibility for Medical Devices

Get to grips with ISO 10993 to ensure optimal biocompatibility testing and evaluations

20 - 21 November 2019

Radisson Blu Edwardian Grafton, London

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.

  • Understand how biocompatibility and biological safety have developed
  • Comprehend the core structure and content of ISO 10993
  • Learn how to categorise devices for biological evaluations
  • Understand how to use the Annex A.1 table to identify end-points
  • Examine materials characterisation
  • Consider when in-vivo testing may be necessary
  • Review sterilisation options
  • Investigate global requirements

Dr Hans Rudorf

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:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing, development and design
  • Toxicology
  • Process development

Official Conference Partner: Life Sciences
Biocompatibility for Medical Devices US

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.

Alumni testimonials:

I enjoyed getting a better understanding of the requirements through the workshop!

Quality Engineer, Bespak


The course provided full knowledge on the topic, also covered all of ISO 10993 and international aspects.

Clinical Project Scientist, JRI Orthopaedics


Navigating Pricing and The Reimbursement Landscape in Europe

Over c 30 minutes, Emmanuel Garnier (Lawyer at Simmons & Simmons), a specialist in advising clients on pricing and reimbursement strategies, talks through pathways in France, Germany and the UK.

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, trainer for MDTI's 'Understanding ISO 13485:2016 - Online Academy' course, this c. 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

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