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Dr. Albert Roossien

Regulatory Lead, BSI

Dr. Albert Roossien is Regulatory Lead BSI Notified Body NL (NB 2797). He holds MSc in Medical Biology (physiology, neurology) & PhD Degree (Cardiovascular Research) at Medical Dept, University of Groningen. He joined the Medical Industry in 1997 as CRA & RA Mgr participating in development of Vascular Devices (Catheters, Stents, Filters) and Intra Ocular Lenses. He joined BSI 2017 as member of the Regulatory Team and involved in Designations, QMS procedures, Competence Verifications, Training.


Situation with Notified Bodies

Location Darwin room Start / end time 3:00 pm to 4:00 pm

Five Notified Bodies will be represented during this session. They are all designated under MDR and for a few also under the IVDR.

Through a panel discussion, we will tackle current challenges both for the manufacturers and for them, in an interactive manner where the audience can also ask questions.

This session will also be the opportunity to get their feedback on submissions and areas of improvements in order to ensure a smoother review process.