Webinar: From idea to MDR approval
About the event
In collaboration with Trondheim Tech Port, Norway Health Tech is hosting a webinar where Bulbitech will share their journey from idea to MDR approval, along with their experiences with DMP inspections. Take this opportunity to learn and ask questions!
Description
This webinar is for everyone working with the development of medical devices. You will gain insights, hear experiences, and have the opportunity to ask questions.
Bulbitech will present their journey from idea to MDR approval – from concept development to ISO 13485 and Class I approval, and how they transitioned from Class I to Class IIa under MDR requirements. They will also share their market strategy and launch plan.
In addition, they will share experiences from preparing for and undergoing a DMP inspection.
This webinar is held in Norwegian.
Program
09:00 – Welcome
🔹 Lena Nymo Helli, CEO of Norway Health Tech, opens the webinar with insights into why regulatory understanding is crucial for growth and scaling in the health technology industry.
09:05–09:45 – From Idea to MDR Approval and DMP Inspection – Bulbitech’s Journey
- From Idea to MDR at Bulbitech, by Bård Dalhøi
- DMP Inspection – Preparation and Regulatory Oversight, by Jørn Kværness
💡 Bård Dalhøi and Jørn Kværness from Bulbitech share concrete experiences, pitfalls, and success factors – valuable lessons for everyone developing medical technology.
09:45–09:55 – Q&A
🔹 Ask your questions directly to the experts – and get the answers you need.
09:55 – Closing
🔹 Lena Nymo Helli wraps up with reflections and the way forward for the ecosystem.
