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Understanding Biocompatibility for Medical Devices

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

Next dates: 6-7 Nov 2017; Bookings open for 8-9 May 2018

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.

  • 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

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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