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 – Meeting room: Auditorium
Program
| 08:30 | Networking, registration, and light breakfast |
| 09:00 | Welcome David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 09:05 | Company Introduction, PharmaLex (becoming Cencora) Torben Thers Norgaard, Head, Nordic region, PharmaLex |
| 09:15 | How to tackle typical MDR 2017/745 QMS Audit and Technical Documentation review process findings? Piritta Maunu, Senior Manager, Regulatory Affairs, Medical Devices, PharmaLex |
| 09:35 | 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 |
Speakers
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Tiina Riihimäki, PhD Director, Head of Medical Devices / IVDs Nordics, PharmaLex Nordics Tiina holds a PhD degree on medical technology from the University of Tampere, Finland. Additionally, she is a graduate of University of Jyväskylä, Finland where she completed her M.Sc. (Chemistry) studies. Tiina has over 15 years, experience working in both the academy and in highly regulated medical device and diagnostics industry. She has versatile scientific, conformity assessment and industry background and has in-depth knowledge of various medical technologies, state-of-art methods as well as EU MD/IVD regulatory requirements, and quality management systems covering the entire life cycle of a medical device or combination drug-device. Tiina has over 5 years Notified Body experience containing various roles including lead auditor role and technical/medical assessor roles. Additionally, she has been working in the MDCG mirror working group as a Team-NB member. |
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Piritta Maunu, Senior Manager, Regulatory Affairs, Medical Devices, PharmaLex Nordics Piritta has a master’s degree in Cellular and Molecular Biology and also holds a teaching qualification. Both degrees are from the University of Jyväskylä, Finland. Piritta is a professional medical device expert with more than 20 years of experience both in vaccine and medical device manufacturers and in a notified body. Her specialties include ISO 13485 and GMP quality management systems, EU MDR, combination products, EU IVDR, companion diagnostics, sterilization techniques, auditing, technical documentation as well as industrial measurement products, services, software and systems. |
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