Expert Quality and Regulatory Solutions

We help medical device and digital health companies navigate EU MDR/IVDR, UKCA, US FDA and worldwide requirements with strategic, lean and evidence-based consulting

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What We Do

At QRA Medical, we are committed to providing top-notch consultancy services in quality assurance and regulatory guidance. We work with medical device startups, scale-ups and global companies across multiple jurisdictions

We believe that every medical device deserves a clear path to compliance. Our core services include:

Regulatory Strategy (UKCA, EU MDR/IVDR, USA 510k, De Novo, PMA and Worldwide)
Quality Management Systems (ISO 13485, 21 CFR Part 820, EU MDR Article 10(9) and MDSAP)
Due Diligence & Gap Assessments
UK Responsible Person & PRRC (Person Responsible for Regulatory Compliance)
Clinical Evaluation
Software & AI/ML Compliance

Our Offerings

01.

Regulatory Affairs

Navigate complex regulatory pathways effortlessly. Our regulatory affairs services ensure compliance with EU MDR, UK MDR, IVDR, US FDA and worlwide requirements

02.

Quality Assurance

Ensure your products meet the highest quality standards. Our quality assurance services establish robust systems to meet regulatory demands and standards including but not limited to ISO 13485, ISO 15189, ISO 9001, ISO 27001, EU MDR Article 10(9), 21 CFR Part 820 and MDSAP

03.

Clinical

We support the full clinical lifecycle, from planning through to post-market activities, across the EU, US and global markets. This includes Clinical Evaluation Reports (CERs), PMCF plans and literature reviews aligned with EU MDR, MEDDEV 2.7/1 rev. 4, FDA expectations and international guidance. Our approach ensures your clinical evidence is regulator-ready, risk-appropriate and justifiable across multiple jurisdictions. Whether you’re relying on equivalence, real-world data or need new clinical investigations, we guide you through every step

Contact Us for Expert Guidance

Let’s work together to ensure your compliance and success in the medical field.

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