Medicon Valley Alliance and Greenlight Guru are pleased to invite you to this Full Day Conference on the 16th of May in Copenhagen.
Greenlight Guru’s mission is to improve the quality of life by helping device makers imagine, introduce and advance higher quality devices faster, with less risk. Since the very beginning, we’ve been dedicated to educating the medical device industry, redefining best practices, and keeping you ahead of the ever-changing regulations.
This is how the True Quality Roadshow was born! Each year, we travel across the United States and Europe to bring together MedTech leaders in quality, regulatory, clinical, and product development for learning, networking, and inspiration.
Our next stop is in Copenhagen where expert speakers will share their insights on EU MDR and US FDA go-to market/study launch & execution. The event features engaging panel discussions, breakout sessions across Clinical & QA/RA topics, and a live recording of our Global Medical Device Podcast, hosted by Etienne Nichols.
The day wraps up with drinks and canapes during a networking happy hour. Join us on May 16th to connect with industry leaders and the local MedTech community, attend engaging sessions, and enjoy ample networking that is sure to deliver important connections and learnings.
Date: Thursday 16th of May 2024
Time: 9:00 – 17:30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 09:00 | Networking, Registration, and Light Breakfast |
| 10:00 | Welcome and Introduction David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance Pall Johannesson, Vice President EMEA, Greenlight Guru Etienne Nichols, Medical Device Guru, Greenlight Guru |
| 10:15 | EU MDR: Insights and success strategies for market entry In this session, the panelists will dive into the current challenges of MDR compliance, explore the impact of the regulation on market entry strategies, and discuss the nuances of navigating the certification process with Notified Bodies. There will be an opportunity for live Q&A. Bassil Akra, CEO, Akra Team Enrico Perfler, Founder, 1MED Helene Gustafsson, Director Clinical Value Proposition & Evidence, GE Healthcare Ralf Gansel, Department Manager, TÜV SÜD Etienne Nichols, Medical Device Guru, Greenlight Guru |
| 11:00 | Networking Break |
| 11:15 | Breakout Sessions
QA/RA: Clinical: Achieving MDR Certification for Legacy Devices |
| 12:00 | Lunch and Network |
| 13:15 | Going to the U.S.? Navigating Regulatory Requirements Details coming soon Karandeep Singh Badwal, Founder, QRA Medical Anette Kristiansen, Senior Clinical & Scientific Affairs Director, Neurescue Edwin Lindsay, Principal Consultant/Managing Director, Compliance Solutions (Life Sciences) Etienne Nichols, Medical Device Guru, Greenlight Guru |
| 14:00 | Networking Break |
| 14:15 | Breakout Sessions (QA/RA and Clinical) QA/RA: Planning: A Strategic Approach to Compliant Medical Device Design Bostjan Barbis, Rook Quality Systems Clinical: Strategies for EU Clinical Evidence Generation Bassil Akra, CEO, Akra Team |
| 15:00 | Networking Break |
| 15:15 | The Global Medical Device Podcast: Live – True Quality Stories in MedTech Hear the personal narratives of MedTech leaders who offer real-world, actionable best practices for industry professionals towards future innovation and implementation of True Quality medical devices. Marcus Carstensen, Co-Executive Director, CTO & Co-Founder, Optoceutics Morven Shearlaw, Co-founder & Director, Fearsome Etienne Nichols, Medical Device Guru, Greenlight Guru |
| 16:00 | Networking, Drinks and Snacks |
| 17:30 | End of Seminar |
Speakers
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Etienne Nichols Medical Device Guru, Greenlight Guru |
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Pall Johannesson Vice President EMEA, Greenlight Guru |
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Peter Seblius Founder and CEO, Medical Device HQ |
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Bassil Akra CEO, AKRA TEAM |
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Helene Quie CEO & Founder, Qmed Consulting |
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Edwin Lindsay Principal Consultant/Managing Director, Compliance Solutions (Life Sciences) |
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Anette Kristiansen Senior Clinical & Scientific Affairs Director, Neurescue |
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Helene Gustafsson Director Clinical Value Proposition & Evidence, GE Healthcare |
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Karandeep Singh Badwal Founder, QRA Medical |
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Marcus Carstensen Co-Executive Director, CTO & Co-Founder, Optoceutics |
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Morven Shearlaw Co-founder & Director, Fearsome |
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Enrico Perfler Founder, 1MED |
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Ralf Gansel Department Manager, TÜV SÜD |
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Boštjan Barbiš Rook Quality Systems |
| Organized by | In collaboration with |
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