US or Europe first? Finding the right regulatory path for your MedTech innovation
Bringing a medical device to market involves some crucial decisions. Should you start in Europe or the US? How do your intended purpose and clinical claims influence your regulatory strategy? And what are the implications of the choices you make early on? During our interactive workshop with supporting partner Qserve, MedTech entrepreneurs explored these questions and discovered why there is no one-size-fits-all approach to market access.
From regulatory challenges to strategic choices
Together with Qserve, Briskr welcomed an engaged group of MedTech founders and professionals eager to explore the regulatory and clinical pathways in Europe and the United States.
Rather than focusing on regulations alone, the workshop encouraged participants to look at their own innovations and the strategic decisions ahead. Through practical explanations, discussions and questions, the group explored the differences between the European MDR and US FDA pathways, the role of clinical evidence and the impact of defining a medical device’s intended purpose and claims.
One of the key takeaways? Your regulatory strategy starts much earlier than you might think. Decisions about intended purpose, clinical studies and product claims can significantly influence your route to market. Understanding these implications early on can help prevent costly changes further down the road.
The session also challenged some persistent assumptions about European market access, including concerns about lengthy waiting times.
An engaged audience and valuable discussions
As we like to see at Briskr workshops, participants came prepared with questions, shared their own challenges and actively contributed to the discussions.
Their feedback highlighted the practical value of understanding the differences between MDR and FDA pathways, the importance of clinical strategy and the consequences of changing a device’s intended purpose or claims.
All participants who completed the evaluation indicated that they would recommend the workshop, with particularly positive feedback on the trainers, content and organisation.
Congratulations to Noviotissue!
The workshop ended with a special surprise. Alejandra Ruiz Zapata, PhD, from Noviotissue won free access to the Qserve Learn Startup Suite!
This e-learning programme, valued at €3,500, provides access to 15 modules covering the essentials of regulatory affairs, clinical strategy and quality management, helping MedTech startups build the knowledge they need to bring their innovations to market.
Congratulations, Alejandra! We hope the program will provide valuable support on Noviotissue’s journey to market.
Continuing the journey with Qserve
As a supporting partner of Briskr, Qserve actively contributes its expertise to help startups navigate the complex world of medical device development and market access. This workshop was another example of how access to experienced industry professionals can help entrepreneurs make more informed decisions.
Exclusive offer for startups at Qserve MedTech Conference
And there is more to come! From 10–12 November 2026, the 6th Qserve MedTech Conference will take place in Amsterdam, bringing together MedTech professionals, industry experts and entrepreneurs. The conference includes a dedicated Start-up Stream, offering practical insights into regulatory strategy, clinical challenges, quality management and scaling a MedTech business.
To make this opportunity more accessible to our community, Qserve offers Briskr startups special registration rates, including a 2-for-1 offer and a 30% discount on individual tickets. Interested? Simply contact training@qservegroup.com and mention Briskr.
Learn more about the Qserve MedTech Conference .
A big thank you to the Qserve team for sharing their expertise, engaging with our entrepreneurs and making this another valuable Briskr workshop!
