MD QMS Ltd. is a UK consultancy helping MedTech, SaaS, FinTech and AI businesses get certified, stay compliant, and build the technology foundations to scale — through two specialist divisions working side by side.
MD QMS Ltd. is a UK-based consultancy specialising in compliance, certification, and technology consulting. We work with MedTech companies, SaaS businesses, FinTechs, and AI startups that need to navigate complex regulatory and operational challenges without hiring full-time expertise.
Founded and led by a husband-and-wife team with hands-on experience on both sides of the table — compliance and quality leadership, and Azure cloud & cybersecurity engineering — MD QMS brings technical depth and regulatory rigour into every engagement.
Manufacturers navigating EU MDR, UK MDR, FDA and ISO 13485 from gap analysis through to certification.
AI-enabled diagnostics and digital health businesses needing QMS, cybersecurity and regulatory alignment together.
Growth-stage software businesses building ISO 27001, ISO 9001 and Azure security foundations to win enterprise trust.
AI startups and scaling technology businesses needing ISO 42001, cloud strategy, and fractional technology leadership.
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 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.
View LinkedIn profile →Two specialist teams. One standard of work.
ISO 9001 · ISO 13485 · ISO 27001 · ISO 42001 · EU MDR · UK MDR · FDA. We build and align Quality Management Systems that get you certified and keep you compliant.
Azure security · Cloud strategy · Process design · Technology roadmap · vCISO · Fractional CTO. We help technology-driven businesses build the operational and security foundations to scale.
We only work in compliance and technology consulting. No distractions, no junior teams.
Every engagement is scoped upfront. You know exactly what you're paying and what you're getting before we start.
Our consultants understand cloud architecture, cybersecurity, and ISO standards — a rare combination for regulated industries.
We embed into your business, not just deliver reports. Everything we produce is built for your team to own and maintain.
Book a free 30-minute discovery call. We'll understand your situation and tell you exactly what an engagement would involve — no obligation.
Book a discovery call