ISO 13485 Excellence: Med-Di-Dia’s Proven Quality Management Expertise

Med-Di-Dia specialises in helping medical device and IVD companies build, refine, and maintain world-class Quality Management Systems compliant with ISO 13485. With deep regulatory expertise and hands-on industry experience, we support organisations at every stage—from developing their first QMS (suitable for micro companies) and during scale-up to optimising mature systems for global market access. We can also provide a hosted e-QMS platform along with our consultancy support.

If a company's goal is rapid expansion, we can guide and support you through the Medical Device Single Audit Program (MDSAP) process which means only one regulatory audit is required giving you immediate access to the US, Canada, Brazil, Australia and Japan.

Our services include gap analyses, risk management integration, design and development processes, document and record controls, supplier management, post-market surveillance, internal audits, and preparation for notified-body and regulatory inspections. We tailor our approach to each client’s technology, team, and market strategy to ensure compliance, scalability, and operational efficiency.

Whether you're a start-up preparing for certification or an established manufacturer strengthening your quality framework, Med-Di-Dia provides practical, compliant, and efficient QMS solutions enabling safe and effective medical technologies in the home or in the clinic providing relief to patients throughout the world.