True Quality Roadshow - Copenhagen Denmark
Event Information
| Event Date | 16-05-2024 9:00 am |
| Event End Date | 16-05-2024 3:00 pm |
| Individual Price | Tickets are free - but space is limited! |
| Location | Medicon Valley Alliance |
Network. Learn. Grow
This event offers a unique opportunity to network, learn from peers, and grow with new strategies to elevate your company to the next level.
Agenda
9:00 AM: ARRIVAL & NETWORKING
Enjoy networking with your MedTech peers!
10:00 AM: WELCOME
10:15 AM: EU MDR: INSIGHTS & 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.
Featuring Bassil Akra, Enrico Perfler, Helene Gustafsson, Ralf Gansel, & Etienne Nichols
11:00 AM: NETWORKING BREAK
11:15 AM: 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
This session will outline the necessary steps for legacy medical devices to meet new MDR standards, starting with a gap assessment in clinical data. It will also detail the creation of a clinical evaluation plan and strategies for engaging with regulatory authorities to streamline the approval process.
| Helene Quie, CEO at Qmed Consulting
12:00 PM: LUNCH & NETWORKING
1:15 PM: GOING TO THE U.S.? NAVIGATING REGULATORY REQUIREMENTS
Details coming soon!
Featuring Karandeep Singh Badwal, Anette Kristiansen, Edwin Lindsay, and Etienne Nichols
2:00 PM: NETWORKING BREAK
2:15 PM: BREAKOUT SESSIONS
- QA/RA: Planning: A Strategic Approach to Compliant Medical Device Design
The talk will define a systematic approach used in early development of new devices to target compliance efficiently. The device's requirements shall be identified and transformed into verifiable design inputs followed by quality assurance plans, and overall verification strategy. Risk of missing requirements not planned shall be addressed as product compliance risk, and business risk. | Bostjan Barbis, Head of Solution Delivery Europe, Rook Quality Systems - Clinical: Strategies for EU Clinical Evidence Generation
Achieving compliance with EU MDR 2017/745 is still a challenge for many manufacturers. One of the main topics leading to continuous round of questions and challenges with Notified Bodies is the clinical evaluation report. During this session, we will discuss the various possible pathways to achieve EU MDR compliance by addressing sufficiency of clinical evidence for legacy or new devices, methods to fulfill PMS & PMCF, etc.
| Bassil Akra, CEO at Akra Team
3:00: NETWORKING BREAK
3:15 PM: 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.
Featuring Marcus Carstensen, Morven Shearlaw, & Etienne Nichols
4:00 PM: NETWORKING, HORS D'OEUVRES, & DRINKS
5:30 PM: EVENT ENDS
*We are still finalizing the agenda and details above are subject to change
Here is what you can expect:
NETWORKING
NO icebreakers, NO name games, just MedTech professionals who are excited to network with peers and enjoy our specialty drinks and hor d'oeuvres.
PANEL DISCUSSIONS
Morning and afternoon panels where medical device leaders will share strategies, key takeaways, and best practices on market entry in the EU and United States.
LIVE PODCAST
Experience a live recording of the Global Medical Device Podcast where Etienne Nichols sits down with some of the best minds in Medtech to get actionable insider knowledge.
ABOUT THE ROADSHOW
The Greenlight Guru True Quality Roadshow brings together MedTech leaders in quality, regulatory, clinical, and product development to connect with their local MedTech community, learn exclusive industry insights, and find inspiration to continue improving the quality of life.
Join us (for free!) to connect with expert speakers, attend engaging workshops, and enjoy ample networking that is sure to deliver important connections and learnings just for MedTech leaders in this new era of work.
Connect With Your MedTech Community
The True Quality Roadshow is a free event series hosted by Greenlight Guru.
The events offer a unique opportunity to connect with peers, gain insight into industry best practices, and get inspired by some of the most knowledgeable minds in MedTech.
Come join us in one of four cities by registering today!
Venue Information - Medicon Valley Alliance
Speakers
Bassil Akra CEO
AKRA TEAM GmbH
Karandeep Singh Badwal
Founder | QRA Medical
Boštjan Barbiš
Head of Solution Delivery Europe | Rook Quality Systems
Marcus Carstensen
Co-Executive Director, CTO & Co-Founder | Optoceutics
Ralf Gansel
Department Manager | TÜV SÜD
Anette Kristiansen
Senior Clinical & Scientific Affairs Director | Neurescue
Edwin Lindsay
Principal Consultant/Managing Director | Compliance Solutions (Life Sciences)
Enrico Perfler
Founder | 1MED
Helene Gustafsson
Director Clinical Value Proposition & Evidence | GE Healthcare
Etienne Nichols
Medical Device Guru | Greenlight Guru
Pall Johannesson
EVP Commercial Division | Greenlight Guru
Helene Quie
CEO & Founder | Qmed Consulting
Peter Sebelius
Founder & CEO | Medical Device HQ
Morven Shearlaw
Co-founder & Director | Fearsome
Related Events
Network. Learn. Grow
This event offers a unique opportunity to network, learn from peers, and grow with new strategies to elevate your company to the next level.
Network. Learn. Grow
This event offers a unique opportunity to network, learn from peers, and grow with new strategies to elevate your company to the next level.