MedTech founders
Milestones without a documentation army.
Design-partner program · limited slots
MedTech compliance that stays alive
MedicaCompli AI converts static medical device documentation into a living evidence graph — AI-mapped traceability for EU MDR, IVDR, FDA 510(k), ISO 14971, and IEC 62304 as the product evolves.
~50%
less RTM thrash*
Hours
to first draft*
100%
human-approved
*Design-partner observations with early-stage device teams — not a guaranteed outcome.
Product preview — illustrative Class IIa workspace
EU MDRIVDRFDA 510(k)ISO 14971IEC 62304ISO 13485Class IIaTraceabilityEU MDRIVDRFDA 510(k)ISO 14971IEC 62304ISO 13485Class IIaTraceability
The problem
Medical device regulatory evidence still lives in spreadsheets
A Class IIa file can hold 100+ interdependent objects across requirements, risk, and verification. One design change breaks the chain.
Industry observation*
~50%
of QA/RA time often goes to rebuilding matrices — not regulatory decisions.
*Exploratory conversations with early-stage device teams.
Broken links
Design revisions desynchronize requirements, risks, and evidence.
Late discovery
Gaps surface at external review — when remediation costs most.
No single source
The full evidence chain is rarely one system of record.
Static by default
Each change forces a partial or full matrix rebuild.
Product
From document pile to a living MedTech evidence graph
AI proposes structure across the regulatory file. Your QA/RA team accepts, edits, or rejects every link.
- 01
Connect documentation
Ingest requirements, risk files, protocols, and reports from existing repositories.
- 02
Map the evidence graph
AI proposes links across requirements → risks → verification → evidence.
- 03
Identify gaps
Surface missing links before notified-body review — not after.
- 04
Export a living package
Keep the matrix aligned as design changes — without a full rebuild.
AI-generated RTM
Parse documents and propose relationships so work starts from structure.
Living compliance model
Evidence stays linked as design changes are introduced.
Human-in-the-loop
Nothing ships to an auditor without an explicit human decision.
Outcomes
Same submission requirements. A different operating model.
What changes for manufacturers and the consultants who support them.
Months → hours
Faster path to submission
Structured first draft of the RTM in hours, then iterate with design.
Earlier detection
Fewer rework cycles
Missing links surface before design freeze and external review.
Lower overhead
Reduced RA thrash
Less manual matrix upkeep for manufacturers and consultants alike.
Before
- Spreadsheets and broken hyperlinks
- Matrix rebuild on every design change
- Gaps found at notified-body review
With MedicaCompli AI
- Living graph of requirements, risks, tests, evidence
- Relationships update as the product evolves
- Gaps found during development, not at review
Who it's for
Heads of QA / RA
Capacity back from manual RTM upkeep.
Regulatory consultants
Standardize multi-client delivery.
Trust
Design partners and advisors
Domain expertise in QA/RA and MedTech leadership — not generic AI advisory.
“Traceability work still collapses into spreadsheets the moment design changes. What early-stage teams need is structure that stays current — with humans firmly in control of every link.”
Eva Nowak
QA/RA design partner · eNowak Life Science
QA/RA design partner
eNowak Life Science
Led by Eva Nowak
- 20+ years QA/RA for medical devices
- 50+ MedDevice customers supported
- Published author and industry trainer
Collaborates on pilot workflow design — not a product endorsement.
View partner
Regulatory design partner
Vysyo
Founded & led by Kai Marcus
- Founder & leader of Vysyo — vysyo.com
- Physician-led regulatory and clinical strategy
- Market access and quality management for MedTech
Collaborates on pilot workflow design — not a product endorsement.
Visit vysyo.comCustomer advisory board
Junko Takahashi
Managing Director, Europe
35 years · Medikit Europe GmbH
About MedicaCompli AI
A product company, not a documentation agency
We ship software for MedTech teams who must keep submission evidence current — without building a second regulatory department.
Focus
Early-stage manufacturers and the QA/RA professionals who support them.
Model
Design-partner pilots first — scoped to real device classes and target markets.
Boundary
We provide tooling and structure. Regulatory judgment stays with your experts.
Prefer email? huyen.le@medcompl.ai
Frequently asked questions
Regulatory due diligence
Questions typically raised by QA/RA leads before a design-partner engagement.
Prefer to talk through your documentation state?
30 minutes with the MedicaCompli AI team.
Founders, heads of QA/RA, and regulatory consultants supporting early-stage medical device manufacturers preparing technical documentation for formal submission pathways.
Evidence structures used in EU MDR and IVDR, FDA 510(k), ISO 14971, IEC 62304, and ISO 13485. Fit for a specific device class and region is confirmed on the call.
No. It proposes structure and relationships only. Qualified QA/RA personnel accept, reject, and own every link — human control is mandatory.
Before production ingestion, storage, access controls, encryption, residency, and subprocessors are aligned with the customer’s policies and agreed in writing.
A 30-minute fit discussion of your documentation workflow, device class, and markets — and whether a design-partner pilot makes sense. No obligation to proceed.
Design partner program
Assess fit for your documentation workflow
Review your evidence workflow and device class. Decide together if a pilot is a fit.
- Workflow review
- Device-class fit
- Pilot scoping
Limited pilot slots · No obligation