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Tools to Accelerate Your Certification
Practical templates, guides, and calculators designed to save you time and reduce certification costs.
Guide
EU Market Entry Guide for International Companies
For medical device manufacturers already approved in any non EU market who want to transfer into EU MDR.
Includes:
- 25 point EU MDR transfer readiness checklist
- Evidence guide: what compliance needs to look like
- Readiness report page: top blockers + first 30 day focus
Guide
MDR Readiness Guide for Austrian Startups
A practical guide covering the essentials every startup needs to know before beginning their MDR certification journey.
Includes:
- MDR scope and intended purpose sanity check
- Device classification decision support (incl. software Rule 11)
- Budget planning worksheet + scorecard + 30 day action plan
Calculator
Identify Your Medical Device Class
Find your likely EU MDR class in 5 minutes based on intended use and risk.
Includes:
- Annex VIII question flow
- Class result with short rationale
- Unlimited classifications possible
Calculator
Find Suitable Notified Bodies
Find Notified Bodies that fit your technology in 10 minutes instead of weeks of research.
Includes:
- Match by scope and designation
- Shortlist of suitable Notified Bodies
- All relevant MDR Notified Bodies
Need Personalized Guidance?
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