Tools to Accelerate Your Certification
Practical templates, guides, and calculators designed to save you time and reduce certification costs.
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.
- 25 point EU MDR transfer readiness checklist
- Evidence guide: what compliance needs to look like
- Readiness report page: top blockers + first 30 day focus
MDR Readiness Guide for Austrian Startups
A practical guide covering the essentials every startup needs to know before beginning their MDR certification journey.
- MDR scope and intended purpose sanity check
- Device classification decision support (incl. software Rule 11)
- Budget planning worksheet + scorecard + 30 day action plan
Identify Your Medical Device Class
Find your likely EU MDR class in 5 minutes based on intended use and risk.
- Annex VIII question flow
- Class result with short rationale
- Unlimited classifications possible
Find Suitable Notified Bodies
Find Notified Bodies that fit your technology in 10 minutes instead of weeks of research.
- Match by scope and designation
- Shortlist of suitable Notified Bodies
- All relevant MDR Notified Bodies
Expert Guides by Topic
Deep-dive articles across every aspect of EU MDR compliance, organized by topic to help you find exactly what you need.
MDR Compliance
Foundational guides on EU MDR requirements, classification rules, transition timelines, and regulatory strategy.
Browse MDR GuidesClinical Evaluation
Clinical evaluation reports, literature reviews, equivalence assessments, and PMCF study design.
Browse Clinical GuidesPost-Market Surveillance
PMS plans, PSUR/PMSR reports, vigilance reporting, PMCF, and trend analysis for ongoing compliance.
Browse PMS GuidesTechnical Documentation
Annex II/III documentation, design dossiers, SaMD-specific requirements, and IVDR considerations.
Browse Tech Doc GuidesNeed Personalized Guidance?
Our resources are a great starting point. For tailored advice on your specific certification challenges, let's talk.