Biocompatibility for Medical Devices conference to focus on regulation changes

The Biocompatibility for Medical Devices conference will take place at CCIB in Barcelona at the end of November covering various aspects of the industry.

Speakers with vast experience either working in or researching the industry are likely to discuss the impact of fresh and altered regulation is likely to have on the industry, and medical devices that are used.

A total of 16 speakers who have worked within, and have done relevant research on, the industry will discuss regulatory updates while sharing practical advice and experiences.

The event will be chaired by Henry Sibun, director of Henry Sibun Associates and an external notified body reviewer/lead auditor for TÜV SÜD.

The speakers cover various aspects of the subject of biocompatibility including toxicology, assessment of risks, safety and regulation.

The topics that will be discussed include:

• A review of and examinations of changes to ISO 10993 – the most widely used regulation to assed the biocompatibility of medical devices and materials
• Changes in biocompatibility requirements
• Implementing ISO 109934 – which covers requirements for evaluating the interaction of medical devices with blood
• The threshold of toxicological concern
• Determining toxicological risk based on extractables and leachables data
• Guidance on nanomaterials.

The speakers include:

• Sherry Parker – an expert in the biological evaluation and toxicological risk assessment of medical devices and combination products.
• Lars Magnus Bjursten – a professor of bioimplant research
• Jeremy Tinkler – director of regulatory consultancy and QA at MedPass International
• Christina Reufstuck – a product specialist at TÜV SÜD
• Ron Brown – a retired toxicologist whose research focussed on developing new methods to assess the risk posed by patient exposure to chemical compounds released from medical device materials
• Philip Clay – whose recent work has focussed on designing safety assessment programmes for medical devices
• James Moore – a senior scientist who specialises in biocompatibility safety evaluations for medical devices
• Annelies Vertommen – whose recent work has focussed on chemical characterisation studies for the medical device industry
• Albrecht Poth – who has over 25 years’ experience in the fields of gentoxicity, alternative toxicity and medical devices.e conference begins on 28^th November at CCIB in Barcelona and will last for two days.