Our services
Two disciplines. One client team.
Start from the problem you need to solve. Every service begins with a fixed-price first step, scoped and priced before we start.
MD QMS Assure
Quality and regulatory, done properly.
The quality and regulatory system: ISO 13485, FDA QMSR, EU and UK MDR, EUDAMED and AI governance.
ISO 13485 & FDA QMSR
Build or align your quality system for EU, UK and US markets, from gap analysis to certification.
From £3,000 per standard, gap analysis
View service → Assure · Quality & regulatoryEU MDR, UK MDR & EUDAMED
Technical documentation, economic-operator roles and EUDAMED registration, done right the first time.
From £1,500 market-access check
View service → Assure · Quality & regulatoryAI governance for medical devices
ISO 42001 and the EU AI Act, mapped onto the MDR evidence you already hold.
From £4,000 readiness assessment
View service → Assure · Quality & regulatoryCompliance retainer & internal audit
Independent internal audits, audit preparation and regulatory horizon-scanning, so your certificate stays valid.
From £1,500 per month
View service →MD QMS Apex
Security for regulated products.
The security engineering behind a regulated product: FDA premarket cybersecurity, SBOM and ongoing security leadership.
FDA premarket cybersecurity
SBOM, threat model, security risk management and post-market plan, written by people who read the code and the regulation.
From £4,500 readiness assessment
View service → Apex · Security engineeringMedTech security leadership
Senior security oversight for device and health-software companies, without a full-time CISO.
From £2,000 per month
View service →For existing clients we also provide Azure security reviews, technology roadmaps and fractional CTO support. Ask us on a call.
How an engagement works
Fixed scope. Fixed fee. No surprises.
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Not sure which service you need?
Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.