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Event info
Date:16 May
Time:9:00-17:30
Venue:Medicon Valley Alliance, Copenhagen

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Contact person
Jannie Rask de Vitt

Jannie Rask de Vitt

Network & Event Assistant

jrv@mva.org

+45 2629 2989

True Quality Roadshow 2024

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

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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:
Reflections: Common Mistakes When Bringing Medical Devices to Market
This fast paced, interactive session will distil experience from hundreds of organisations and the most common mistakes and misunderstandings in design controls, risk management, and requirements engineering and include useful hints and tips on how to avoid them and be efficient in medical device product development.
Peter Sebelius, Medical Device HQ & authoring teams for ISO 13485 and ISO 14971

Clinical: Achieving MDR Certification for Legacy Devices
Helene Quie, Qmed Consulting

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​​​​​

 
Etienne Nichols
Medical Device Guru, Greenlight Guru
 
Pall Johannesson
Vice President EMEA, Greenlight Guru
 
Peter Seblius
Founder and CEO, Medical Device HQ

Bassil Akra
CEO, AKRA TEAM
 
Helene Quie
CEO & Founder, Qmed Consulting
 
Edwin Lindsay
Principal Consultant/Managing Director, Compliance Solutions (Life Sciences)

​​

Anette Kristiansen
Senior Clinical & Scientific Affairs Director, Neurescue
 
Helene Gustafsson
Director Clinical Value Proposition & Evidence, GE Healthcare
 
Karandeep Singh Badwal
Founder, QRA Medical
 
Marcus Carstensen
Co-Executive Director, CTO & Co-Founder, Optoceutics
 
Morven Shearlaw
Co-founder & Director, Fearsome
 
Enrico Perfler
Founder, 1MED
 
Ralf Gansel
Department Manager, TÜV SÜD
 
Boštjan Barbiš
Rook Quality Systems

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