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Start Your MedTech Journey Right: Compliance Packages for Start-Ups
Whether you’re preparing your first regulatory submission or refining your evidence plan for investors, we help you get there — fast.
What You Get
Tailored guidance from experts in MDR, FDA, ISO 13485, ISO 14971 & GCP.
Hands-on help with your documents — real deliverables, not just theory.
A focused plan that fits your timeline: 3 days, 5 days, or custom.
Flexible. Modular. Made for You
Remote or on-site
English or German
Fully tailored to your product, maturity stage & goals
Need 2 or 4 days? We adjust the content to your needs
Pick Your Module — or Combine Them All
Plan your strategy, define your pathway. CE marking, 510(k), De Novo, labeling, UDI — mapped and guided.
Regulatory Starter Package
Set up a scalable Quality Management System with ISO 13485 & MDR alignment. Templates, SOPs, and full structure included.
QMS Starter Package
Turn risk into strategy. Build your files (FMEAs, Hazard Analysis), define lifecycle risk planning — FDA & MDR ready.
Risk Management Starter Package
Build smart evidence plans: CIP, PMCF, literature review, and CER — GCP and MDR aligned.
Clinical Starter Package
Super Pack:
5-Day Compliance
Sprint
Need it all? Combine the 4 modules into a 5-day deep dive.
Perfect for:
- Investor due diligence
- Regulatory milestones
- Early market readiness
Includes everything: roadmap, strategies, templates, and a full action plan.
Ready to Accelerate?
Schedule My Free Discovery Call