Director Regulations & Industrial Policy - MedTech Europe
Oliver Bisazza joined MedTech Europe in August 2017. He comes to us from Medtronic, where he served since 2014 as Director of Regulatory Policy for Europe, the Middle East and Africa. In this role, he was also highly active within MedTech Europe, leading and participating in numerous committees and stakeholder alliances.
Prior to joining Medtronic, Oliver was Technical and Regulatory Affairs Manager at COCIR, the European association for the radiological, electromedical and healthcare IT industries. His career in Brussels started with 4 years of progressively responsible regulatory roles within EDANA, the industry association for the nonwovens and related industries.
A dual national of Australia and Malta, Oliver has a Masters degree in Economic Sciences from the University of Wales, where his research focused on European legislative systems and their preparedness for emerging public health threats.
3 blogs from the author
Posted on 25.05.2018
IVDR/MDR transition periods: It’s time to talk about time
One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness. While I’d love to claim the same for all other essential elements of the new regulatory system, progress […]
Posted on 05.03.2018
Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]
Posted on 27.11.2017
Notified Bodies: Into the Mouth of the Wolf?
At long last, the date has arrived. Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their applications as of yesterday, 26 November 2017. In order for the new regulatory system to function as intended, it is essential that these assessment bodies be up-and-running as early as […]