CE marking in weeks, not 18 months.
An AI-powered end-to-end MDR/IVDR conformity assessment platform — from directive classification to a signed Declaration of Conformity. Built for medical device startups that cannot afford to lose a year to regulatory process.
The problem
6–18 mo
Average MDR conformity timeline for a seed-stage device startup
€50k–€500k+
Typical spend on consultants, notified bodies, and legal review
Series A
When most founders realise MDR is blocking their commercial launch
MDR is a 900-page directive that touches every technical file, clinical evaluation, and quality management artefact your device needs before it can be placed on the EU market. Most early-stage teams discover this too late — and the cost is runway, not just money.
How it works
End-to-end conformity — structured and auditable
I
Classify
Input your device description. Conformiq identifies the applicable directive (MDR, IVDR), risk class (I–III), and relevant annexes automatically.
II
Document
AI drafts your technical documentation structure — intended purpose, design dossier, risk management file, and PMCF plan — mapped to Article 10.
III
Gap Analysis
Upload existing materials. Conformiq identifies missing evidence, flags non-conformances, and prioritises remediation against notified body expectations.
IV
Declaration
Outputs a review-ready Declaration of Conformity and complete technical file index — ready for your notified body or authorised representative.
Who it's for
Built for longevity deep tech founders
◈
Wearables & biosensors
Class I/IIa devices collecting physiological data for longevity monitoring or clinical research.
◆
Implantables
Class III devices requiring notified body involvement and clinical investigation data.
◇
IVD diagnostics
IVDR-compliant in-vitro diagnostics for biomarker panels, ageing clocks, or disease risk.
◉
Digital therapeutics
Software as a Medical Device (SaMD) under MDR Rule 11, including AI/ML-driven interventions.
Designed for the regulatory team of one.
Whether you're a CEO holding regulatory yourself, a CTO managing a technical file for the first time, or a first hire in a Head of RA role — Conformiq gives you structured, expert-level guidance without €400/hr consultant rates.
Early access
Stop losing runway to MDR.
We're onboarding a small cohort of seed and Series A medical device startups. Request access and we'll reach out within 48 hours.
No spam. No sales calls unless you want one.