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
- Yana Pozhidaeva, Senior Manager, Clinical Quality Assurance, Abbott
- Graham Tunbridge, Group Manager Devices Regulatory Affairs, MHRA
- ABHI Members Early Bird – £325.00+ VAT
- Non Members Early Bird – £425.00 +VAT
For bookings of more than five delegates, please email email@example.com
Early Bird pricing ends 31st August 2019