MDR: Risk Management as a Key Regulatory Tool

Using Clinical Data and Postmarket Surveillance to drive Compliance

This year’s ABHI flagship conference will focus on the use of risk management as an essential part of the medical device regulatory process. The event will draw on the use of clinical data and postmarket surveillance and their role in effective risk management and how the ISO 14971 standard fits into the overall quality management system for medical devices.

There will be a broad range of speakers from industry, regulators, notified bodies and a Keynote Address from John Round, Head of Airspace, Air Traffic Management and Aerodromes at the Civil Aviation Authority. John will provide a different perspective on the use of risk management techniques in a safety-critical industry.

Once again, this will be an event not to be missed as companies, notified bodies and regulators move ever closer to full implementation of the Medical Device Regulation.

It is also planned to cover Brexit in whatever form is appropriate at the time – watch this space!

“Some risks that are thought to be unknown, are not unknown. With some foresight and critical thought, some risks that at first glance may seem unforeseen, can in fact be foreseen. Armed with the right set of tools, procedures, knowledge and insight, light can be shed on variables that lead to risk, allowing us to manage them.”

― Daniel Wagner,

CEO of Country Risk Solutions, Connecticut. Author of Global Risk Agility and Decision Making: Organizational Resilience in the Era of Man-Made Risk

Confirmed Speakers - More to be added

• Phil Brown, Director, Technical & Regulatory, ABHI
• Suzanne Halliday, Head of Medical Devices, BSI
• Shuna Mason, Partner, Head of Regulatory Life Sciences Group, CMS Cameron McKenna
• James Pink, Vice President NSF Certification Ireland Ltd
• Graham Tunbridge, Group Manager Devices Regulatory Affairs, MHRA
• John Round, Head of Airspace, Air Traffic Management and Aerodromes, Civil Aviation Authority
• Janette Benaddi, Non Executive Director, Medipex
• Martin Penver, Technical Regulatory Manager, SGS
• Alastair Selby, Managing Director, SciMed Consultancy
• Celine Bourgignon, Head of Quality, Regulatory & Clinical Affairs, Cardinal Health
• Mark Wasmuth, CEO, GMDN
• Richard Phillips, Director, Policy and Communications
• John Wilkinson, Director of Devices, MHRA
• Tony Sant, Group Manager, MHRA
• Nicole Small, Unit Manager, MHRA
• Sally Mounter, Data Integrity Team Manager, MHRA

Delegate Pricing

• ABHI Members - £399.00+ VAT
• Non Members - £499.00 +VAT

For bookings of more than five delegates, please email ukevents@abhi.org.uk