Consulting and interim management within medtech.
We streamline product development by considering regulatory aspects, markets, sourcing, production and operations early on — so products reach patients faster.
- Regulatory (MDR / FDA)
- Markets
- Sourcing
- Production (DFX)
- Operations
01
Interim Management
Hands-on leadership for medtech teams in transition, growth or between hires.
02
Technical Files
Structuring and building technical documentation for MDR and FDA submissions.
03
Early Startup Consulting
Guiding founders from concept to a manufacturable, compliant product.
Owner / Advisor
Dr.ing. Arnar Kristjansson
Founder of Xybel AS since December 2018, advising medtech companies on bringing robust, compliant products from idea to market.