SaMD & connected devices
Software and connected-device makers preparing FDA or MDR submissions who need the QMS and the cybersecurity file to tell the same story.
Regulatory + cybersecurity compliance for MedTech
Get to market with a QMS and security file that survive the audit.
ISO 13485, EU MDR, FDA and premarket cybersecurity, delivered by one practitioner team that understands both the regulation and the code. Fixed fees, defined scope, built for your team to own.
ISO/IEC 27001:2022 Lead Auditor ISO 14971 risk management Qualified internal auditor ISO 13485 · EU & UK MDR · FDA QMSR Fixed-fee scope before we start
Who we help
Built for medical-device and health-software teams.
Early-stage MedTech
Funded start-ups building their first certified quality system, written for their team and their product, not a template set.
Digital health & HealthTech
Health-software companies selling to hospitals, insurers and the NHS who need ISO 27001, AI governance and security evidence to close deals.
Services
Six services. One team that does both.
MD QMS Assure builds the quality and regulatory system. MD QMS Apex builds the security engineering behind a regulated product. Every engagement starts with a fixed-price first step.
Assure · Quality & regulatory
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 → Apex · Security engineeringFDA 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 →Dates that matter
The regulatory calendar, translated.
28 Nov 2026
EUDAMED legacy-device registration
Devices placed on the market before 28 May 2026 and still being sold must be registered in EUDAMED’s UDI/Device module.
What it means for you → 2 Feb 2026FDA QMSR in force
21 CFR Part 820 now incorporates ISO 13485 by reference. US-bound manufacturers need a QMSR delta, not a second QMS.
What it means for you → 2 Aug 2028EU AI Act: AI in medical devices
High-risk obligations for AI in products covered by sectoral legislation, including medical devices, apply from this date (AI Digital Omnibus).
What it means for you →How an engagement works
Every engagement starts with the same question: what needs to be true when the work ends?
01
Discover
A free 30-minute call to understand your product, markets and deadline.
02
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
03
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
04
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Leadership
Run by practitioners, not generalists.
You work directly with the people doing the work. No junior hand-offs.
Alex Adamovici
Director
ISO/IEC 27001:2022 Lead Auditor with a security-first background in Azure cloud architecture, identity and access management, and release and risk governance in regulated environments. The technical foundation behind MD QMS Apex.
Full profile →
Mirela Adamovici
Senior Compliance Consultant
Regulatory compliance specialist in GMP, ISO 13485, ISO 14971, MDR, EUDAMED and FDA 21 CFR Part 820. Has built quality systems from the ground up and led ISO certification programmes. The regulatory foundation behind MD QMS Assure.
Full profile →Insights
Latest from the regulatory radar.
Selling into the EU?
Meet our EU sister company, MD QMS SRL.
A Romania-based, EUDAMED-registered EU importer, with an EU Authorised Representative service in development. Your QMS, your security file and your EU economic-operator roles, from one group, with the roles kept separate.
Ready to find your path?
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.