MedTech Startup Accelerator
A fractional RA/QA team, structured in stages. Hiring a full regulatory and quality team is expensive and often unrealistic at an early stage. MedoQi manages your regulatory, quality, clinical and post-market needs, so you can focus on the product and the next funding round.
Five problems we see again and again
Innovation alone won't get a device CE-marked or FDA-cleared. These are the issues that cost startups years and investor confidence.
Late regulatory planning
Treating compliance as an afterthought means rework, lost time and harder investor conversations.
Weak QMS foundations
Do-it-yourself systems often fail at the first audit and need costly rework. A lean ISO 13485 QMS built early avoids that.
Clinical evidence gaps
MDR and FDA expect strong data. Poor evidence planning leads to budget overruns and delays.
Broken design controls
Missing traceability, risk files or usability evidence leads to submission rejections.
Global complexity
FDA, MDR and PMDA all differ. Without a single roadmap, money goes into chasing approvals one by one.
Our answer
Regulatory by design, an audit-ready lean QMS, a clinical evidence strategy and one roadmap for parallel market entry.
Talk to us →Support that grows with your company
Programme stages. Scope and fees are agreed with each company.
Foundation
- Device classification and intended purpose
- Regulatory roadmap for target markets
- Initial gap assessment
Development
- Lean ISO 13485 QMS
- Design controls and traceability
- Risk and clinical evidence planning
Market Access
- Dossier preparation
- Submission readiness assessment
- Regulatory review support
How it works
- 01Discovery callYour device, stage, funding milestones and target markets.
- 02Readiness reviewClassification, gaps and a first regulatory roadmap.
- 03Agreed planStage, scope and staged payments matched to your milestones.
- 04Fractional RA/QA leadA named specialist, with the wider team available when needed.
Why startups choose this model
Expertise on demand
Senior RA/QA specialists when you need them, without permanent headcount.
ISO 13485, right-sized
A quality system that meets ISO 13485 while keeping documentation practical for a small team.
Staged payments
Part or staged payments to ease cash flow. Pay only for the services you use.
A credible plan
A regulatory strategy, budget and timeline you can put in front of investors with confidence.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.