2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap

June 18, 2024

2024 Greenlight Guru True Quality Roadshow Copenhagen Recap

It was a fantastic day in Copenhagen on May 16th! The Greenlight Guru True Quality Roadshow, a sold-out event, brought together a vibrant community of medical device professionals. This unforgettable gathering was more than an event: it was a celebration of innovation, collaboration, and quality in MedTech.

Greenlight Guru partnered with Medicon Valley Alliance, an important Life Science cluster in Northern Europe, to put on the show. The support from our sponsors, Compliance Solutions Life Sciences and 1Med, was instrumental in making this event a success.

The event started with an introduction from Greenlight Guru and Medicon Valley Alliance, setting the stage for a day full of insights and inspiration.

The morning panel, "EU MDR: Insights & Success Strategies for Market Entry," was a major highlight. Bassil Akra, CEO at AKRA Team and Notified Body Reviewer and Auditor, Enrico Perfler - Founder of 1Med, GE Healthcare's Helene Gustafsson, Ralf Gansel of TÜV SÜD, and host Etienne Nichols dove into the current challenges of MDR compliance. They explored the nuances of navigating the certification process with Notified Bodies, providing attendees with invaluable strategies for market entry.

Following the panel, the attendees split into two groups for breakout sessions on Clinical and Quality topics. Peter Sebelius, Founder & CEO at Medical Device HQ and part of the authoring teams for ISO 13485 and ISO 14971, led a lively and informative session. He captivated the crowd by discussing common mistakes and misunderstandings in design controls, risk management, and product engineering. It was both fun and educational, leaving everyone with practical insights and a lot of laughs.

Meanwhile, the Clinical breakout session, led by Helene Quie, CEO at Qmed Consulting, was equally engaging. Attendees were eager to learn how to achieve EU MDR Certification for Legacy Devices. Helene provided valuable tips and insights, answering numerous questions and fostering a dynamic exchange of ideas.

The lunch and networking break followed, offering everyone an opportunity to connect with the local MedTech community.  Attendees exchanged business cards, shared stories and best practices, and ultimately built new relationships—all while enjoying a healthy meal.

After lunch, we gathered for the last panel discussion of the day: "Navigating the U.S. Regulatory Requirements." This session featured Karandeep Singh Badwal, Founder of QRA Medical, Anette Kristiansen, Senior Clinical & Scientific Affairs Director at Neurescue, Edwin Lindsay, Principal Consultant/Managing Director at Compliance Solutions Life Sciences, and host Etienne Nichols. Their insights into the U.S. regulatory landscape were enlightening and actionable.

The final breakout sessions of the day covered two more Quality and Clinical topics. Bostjan Barbis, Head of Solution Delivery Europe at Rook Quality Systems, and Bassil Akra, CEO at AKRA Team led the presentations. They offered proactive strategies and pertinent advice on compliant medical device design and EU clinical evidence generation, leaving attendees equipped with the knowledge to advance their projects.

Another networking break followed, setting the stage for the grand finale - a live session of the Global Medical Device Podcast hosted by Etienne Nichols. This engaging discussion, "True Quality Stories in MedTech," featured CEOs and founders Morven Shearlaw of Fearsome and Marcus Cartensen of OptoCeutics. They shared personal experiences and best practices for future innovation and the implementation of True Quality medical devices.

Of course, this very successful day couldn’t have concluded without a happy hour! Attendees mingled over snacks and drinks, engaging in thought-provoking conversations and making lasting business (and personal) relationships. The energy was fantastic and the sense of community was incredible.

Throughout the day, we saw attendees reconnect with previous colleagues and friends. Many captured the moment with photos, their happy faces and enthusiastic feedback making this sold-out event one for the history books. This sense of belonging and shared purpose is what makes the Greenlight Guru True Quality Roadshow so special. Here’s to many more inspiring gatherings where we continue to learn, grow, and thrive together!

About The True Quality Roadshow

The Greenlight Guru True Quality Roadshow brings together MedTech leaders in quality, regulatory, clinical, and product development to learn industry best practices and trends, meet their local MedTech community, and find inspiration to continue improving the quality of life.

Join us (for free!) to connect with expert speakers, attend engaging sessions, and enjoy ample networking that is sure to deliver important connections and learnings designed exclusively for MedTech leaders.

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle. Greenlight Guru’s...

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