Our Services
Clear, structured and evidence‑driven support across risk management, clinical documentation, and MDR technical requirements.
Designed for MedTech startups, SMEs, and growing manufacturers looking for practical, audit‑aligned guidance.
Risk Management
Support designed to help your team build a compliant, lifecycle‑appropriate risk management framework.
How We Help
- Hazard identification and hazard analysis
- Risk estimation and risk evaluation
- Full risk file creation or remediation
- Benefit–risk determination and justification
- Alignment of clinical, design and risk documentation
- Lifecycle updates for MDR compliance
- Cross‑functional training for R&D, QA, engineering, and PM teams
Who This Is For
Startups building initial risk documentation, SMEs improving their technical files, and teams preparing for audits or MDR submissions.
MDR Clinical Documentation
Clear, structured and evidence‑based documentation that meets MDR expectations and supports device safety and performance claims.
How We Help
- Clinical Evaluation Reports (CER)
- Clinical Evaluation Plans (CEP)
- PMCF plans and PMCF evaluation reports
- Systematic literature searches and critical appraisal
- Clinical evidence mapping and gap analysis
- Support with benefit–risk assessments and GSPR alignment
- Documentation updates for MDR recertification
Who This Is For
Teams preparing for Notified Body review, managing recertification, or needing clarity and structure around MDR‑aligned clinical evidence.
MedTech Compliance
Starter Kit
A focused, fixed‑scope package designed specifically for early‑stage teams.
What’s Included
- 1‑hour risk management strategy session
- 1‑hour clinical documentation strategy session
- ISO 14971 hazard analysis template
- Clinical evidence mapping template
- High‑level documentation gap review
- Clear, actionable roadmap for your next steps
Who This Is For
Founders and small teams beginning their compliance journey who need structure, clarity and support without committing to a full project.
How We Work
We aim to make your documentation process as clear and collaborative as possible.
- Introductory Consultation
We discuss your device, goals, and current documentation. - Defined Scope & Timeline
You receive a clear plan, realistic expectations, and transparent deliverables. - Development & Review
We produce structured, evidence‑based documentation aligned with MDR and ISO requirements. - Support & Follow‑up
We work with you until your documentation is clear, traceable, and ready for internal or external review.
