MedTech Integrity Information

MedTech Integrity is a UK based QA/RA consultancy providing senior regulatory leadership to medical device and Software as a Medical Device (SaMD) organisations operating under EU MDR, UKCA and FDA frameworks. We support MedTech teams preparing for audit, submission, scale or investment by strengthening structural control across quality and regulatory systems. Our focus is not document volume, it is system integrity. Engagement areas include: • EU MDR & UKCA compliance • FDA regulatory strategy & inspection readiness • ISO 13485 QMS development & optimisation • ISO 14971 risk management integration • Technical documentation coherence • PMS & PMCF alignment • PRRC oversight • Audit & due diligence preparation • Fractional QA/RA leadership MedTech Integrity works with startups, scaling SMEs and established device manufacturers to ensure regulatory systems are coherent, traceable and defensible under scrutiny. Compliance maturity is not measured by the number of SOPs. It is measured by clarity, consistency and control. Founder: Jack Bacon Sheffield, United Kingdom