MD Compliance

MD Compliance is a Glasgow-based quality assurance and regulatory consulting firm specializing in medical device manufacturers. Founded in 2015, the company has completed approximately 150 projects for over 80 customers across the UK, EU, United States, and Canada. The firm recently expanded operations with a U.S. office to better serve North American clients.

The consultancy focuses on Quality Management System implementation, international regulatory affairs, clinical evidence compilation, and staff training. Their service portfolio covers compliance requirements for medical devices in multiple jurisdictions including EU MDR, UK MHRA, FDA, and Health Canada regulations. The team provides hands-on support ranging from gap assessments and supplier audits to post-market surveillance and risk management documentation.

MD Compliance positions itself as a resource for startups and small-to-medium enterprises, though they also support larger manufacturers seeking external expertise to supplement internal teams. The firm maintains access to a network of subject matter experts across various global locations to address complex compliance challenges.

Consider MD Compliance when you need hands-on regulatory guidance for medical device market entry across multiple jurisdictions. Their small-team approach may benefit manufacturers who prefer direct access to senior consultants rather than working through layers of account management.

The firm's emphasis on QMS implementation and training suggests they work closely with client teams to build internal capabilities alongside achieving compliance milestones. Their global network positioning enables them to address region-specific requirements efficiently.

MD Compliance operates exclusively within the medical device regulatory space, addressing the specific quality and compliance requirements that govern medical device manufacturing and market authorization. Their services align with the stringent regulatory frameworks imposed by EU MDR, UK MHRA, FDA, and Health Canada for medical devices.

The firm's clinical evaluation services specifically address the clinical evidence requirements mandated for medical device market approval and post-market monitoring, ensuring devices meet safety and performance standards required by healthcare regulators globally.

Medical device manufacturers in growth phases requiring regulatory pathway guidance for EU, UK, or North American markets. Companies with limited internal regulatory resources who need comprehensive QMS development, clinical evaluation support, or post-market surveillance infrastructure. Organizations valuing responsive consulting relationships with experienced practitioners.