Skip to main content
9 Milestones · Interactive Roadmap

Startup Launchpad

Your step-by-step roadmap from idea to regulatory approval

Navigate the regulated product journey with confidence. This interactive guide covers every milestone — from validating your clinical idea to post-market obligations — with real costs, timelines, common pitfalls, and the deliverables you need at every stage.

9

Milestones

1465

Months est.

€165K–€3.3M

Total est.

Cost Overview

Budget by Milestone

Proportional view of estimated investment per stage

1. Idea Validation
€5K–€25K
2. Regulatory Strategy
€5K–€20K
3. QMS Setup
€15K–€80K
4. Design & Development
€50K–€500K
5. Risk Management
€10K–€40K
6. Testing & Verification
€20K–€250K
7. Clinical Evidence
€10K–€2.0M
8. Submission Preparation
€20K–€150K
9. Post-Market & Launch
€30K–€200K

Bar width is proportional to the high-end estimate. Actual costs vary by team, market, and device class.

Investment Phases

Funding Journey

Which milestones typically fall at each funding stage

Pre-seed
1 milestone€5K–€25K
Idea Validation
Pre-seed / Seed
1 milestone€5K–€20K
Regulatory Strategy
Seed
1 milestone€15K–€80K
QMS Setup
Seed / A
2 milestones€60K–€540K
Design & DevelopmentRisk Management
Series A
1 milestone€20K–€250K
Testing & Verification
Series A / B
2 milestones€30K–€2.1M
Clinical EvidenceSubmission Preparation
Series A+ / Revenue
1 milestone€30K–€200K
Post-Market & Launch

Find Your Stage

What Stage Am I?

Answer 5 questions and we'll pinpoint exactly where you are on the regulatory journey.

Question 1 of 8

Where did your product idea come from?

Understanding your starting point helps us gauge how much clinical validation work remains.

0% complete

Full Journey

The Complete Roadmap

Click any milestone to expand the full details — what to do, what to avoid, and what to produce.

Realistic Timeline (parallel activities shown side-by-side)

Idea Validation
1-3mo
Regulatory Strategy
1-2mo
QMS Setup
2-4mo
Design & Development
6-18mo
Risk Management
2-4mo
Testing & Verification
3-12mo
Clinical Evidence
3-36mo
Submission Preparation
3-6mo
06mo12mo18mo24mo36mo48mo

Milestones 5-7 (Risk, Testing, Clinical) can run in parallel with Design & Development, significantly reducing total time.

Milestones Complete

0/9

Remaining Timeline

1465 mo

Remaining Cost Est.

€165K–€3.3M

Ready to build your QMS?

MoniDoseQMS provides everything you need for Stage 3 and beyond — from your first SOP to post-market surveillance.

Cost and timeline estimates are indicative ranges based on industry benchmarks. Actual figures vary by device class, market, and team experience. Always work with a qualified regulatory consultant for your specific situation.