Why are Aurevia and RAPS collaborating on the Medtech Compliance Forum?
The Medtech Compliance Forum by Aurevia & RAPS is a dedicated platform within Labquality Days, bringing together regulatory, quality, clinical and technical perspectives to address the real-world challenges facing the medtech industry.
We asked Mika Siitonen, Operations Manager, Digital Health at Aurevia and lead for the Medtech Compliance Forum, to explain the thinking behind the collaboration and, above all, what it offers regulatory professionals and medtech companies.
”Regulatory professionals rarely suffer from a lack of information. There is plenty of it, even too much.”
The real challenge is understanding what matters, what it means in practice, and what should be done next, while remaining in control of the bigger picture.
”That is why collaboration matters.”
For RAPS, the collaboration creates a stronger connection with the Nordic medtech community, building on the 50-year history and established network of Labquality Days and its medtech tracks. For Aurevia, it creates a more direct bridge between our regional ecosystem and the global regulatory community.
But the real value is not what the collaboration brings to either organisation. It is what it brings to the people and companies we serve.
”For me, the value lies in bringing an even broader range of international regulatory thinking into the conversation and connecting it with the questions companies are dealing with every day.”
What evidence will be sufficient? How should new technologies be approached? What will authorities and notified bodies expect? And how can responsible decisions be made when the regulatory path is still evolving or uncertain?
By bringing regulatory, quality, clinical and technical perspectives into the same conversation, the Forum allows participants to examine different interpretations, share practical experiences and discuss openly both what we know and where uncertainty still remains.
This is the thinking behind the Medtech Compliance Forum by Aurevia & RAPS, part of Labquality Days in Helsinki. Together, we want to create a place where global regulatory insight meets the Nordics on a larger scale, and where regulatory excellence becomes part of how companies make better decisions, build safer products, grow stronger and achieve sustainable access to international markets.
”I hope the Forum becomes a place where regulatory professionals do not simply receive more information, but leave with greater clarity, useful connections and a better understanding of what to do next.”