Regulatory Services
From MDR strategy and gap analysis to technical documentation — we design your path to CE marking.
Typical challenges
- The CE marking process is complex
- Heavy documentation workload for NB submissions
- Unclear post-market surveillance requirements
What we provide
- MDR strategy
- Device classification and the shortest route to conformity
- Gap analysis
- Identify gaps between current documentation/QMS and MDR requirements
- Technical documentation
- Documentation structured per Annex II/III
How we work
- 1Initial consultation (free)
- 2Gap analysis & strategy proposal
- 3Hands-on documentation support
- 4NB submission support
Related services
Start with a free 30-minute consultation
We help you map your current position: device class, CE status, and EU clinical investigation plans.
Book a free consultation