About MD QMS

Practitioners on both sides of the table.

MD QMS Ltd. is a UK consultancy, founded and led by a husband-and-wife team with hands-on experience in medical-device quality and regulation, and in cloud and cybersecurity engineering. We help medical-device and health-software companies get certified, get cleared and stay compliant.

Leadership

The people you’ll work with.

Alex Adamovici

Director, MD QMS Ltd.

Alex is an ISO/IEC 27001:2022 Lead Auditor with a security-first background spanning Azure cloud architecture, identity & access management, and infrastructure engineering across regulated industries. He designs and implements security-and-compliance frameworks aligned to ISO/IEC 27001:2022, embedding security-by-design across cloud platforms and delivery pipelines.

His certifications include ISO/IEC 27001:2022 Lead Auditor and ISO 14971 Medical Device Risk Management, alongside a career built across cloud infrastructure, identity engineering and release & risk governance in regulated environments — the technical foundation behind MD QMS Apex.

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Mirela Adamovici

Senior Compliance Consultant, MD QMS Ltd.

Mirela is a regulatory compliance specialist with deep, hands-on knowledge of GMP, ISO 13485, ISO 14971, ISO 9001, MDR, EUDAMED and FDA 21 CFR Part 820. She has implemented and maintained quality management systems from the ground up, led ISO certification programmes, and works as a qualified internal auditor.

Alongside compliance, she brings a strong procurement and logistics background — supplier qualification, import/export operations, customs compliance and international shipping — the operational rigour behind MD QMS Assure’s approach to documentation that survives real supply chains and real audits.

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How we work

Four principles behind every engagement.

Specialist depth

We only work where regulation and technology meet in regulated products. No generalist menu, no junior teams.

Fixed scope, fixed fee

Every engagement is scoped and priced before we start. You know what you get and what it costs.

Both sides of the table

We read the regulation and the code. Your QMS and your security evidence are built to tell the same story.

Built for you to own

We embed with your team. Everything we write is designed for you to maintain after we leave.

Two divisions

One company, two disciplines.

MD QMS Assure: The quality and regulatory system: ISO 13485, FDA QMSR, EU and UK MDR, EUDAMED and AI governance.

MD QMS Apex: The security engineering behind a regulated product: FDA premarket cybersecurity, SBOM and ongoing security leadership.

MD QMS SRL, our Romania-based sister company, is registered in EUDAMED as an EU importer, with an EU Authorised Representative service in development. Visit MD QMS SRL →

Company details

Registered name: MD QMS LTD
Company number: 14499573
Registered in: England and Wales
Registered office: 9 Upland Road, St Helens, England, WA10 3SQ
Working: Remote and on-site across the UK

Let’s talk about your product

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.

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