Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 23rd of January in Copenhagen focusing on:
How to successfully address non-conformances raised by your Notified Body? Key learnings for the medical device manufacturers and to the Notified Body Opinion (NBOp) applicants
Topics will include:
• Typical Notified Body findings from MDR 2017/745 QMS Audits and Technical Documentation Review
• How to respond to Notified Body findings?
• Main challenges and lessons learned on the Notified Body Opinion (NBOp) process for Drug-device combinations
Date: Tuesday 23rd of January 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Auditorium
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Program
8:30 Networking, registration and light breakfast
9:00 Welcome
David Munis Zepernick, Director, Member Engagement and Communication, Medicon Valley Alliance
9:05 Company introduction, PharmaLex (becoming Cencora)
Torben Thers Norgaard, Head, Nordic region, PharmaLex
9:15 How to tackle typical MDR 2017/745 QMS Audit and Technical Documentation review process findings?
Piritta Maunu, Senior Manager, Regulatory Affairs, Medical Devices, PharmaLex
9:35 Examples from successful MDR Article 117 Drug-device Combination product NBOp processes
Tiina Riihimäki, Director, Head of Medical Devices/IVDs Nordics, PharmaLex
10:00 Q&A session
10:15 Networking
11:00 End of Good Morning Meeting
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