About Compliance MedQRA

Global regulatory consulting and eQMS built by people who have led compliance from inside real MedTech and SaMD companies

Our Story

Compliance MedQRA was founded to solve a recurring problem: innovative health-tech teams drowning in regulatory complexity and generic advice.

With roots in Europe and the UAE, and experience as internal QA/RA leaders in MedTech and SaMD companies, we know exactly how it feels to balance product roadmaps, clinical expectations, and regulatory deadlines.

We built a consulting practice and QraOne eQMS to make compliance practical, understandable, and scalable.

Our Approach

Product-Driven

We start from your clinical and business goals, then shape the regulatory and QMS pathway around them

Lean & Practical

No 200-page documents nobody reads. We focus on what regulators expect and your team can realistically maintain

Transparent & Collaborative

We work as an extension of your team, sharing knowledge so you become stronger internally

Long-Term Partners

From first submission to lifecycle changes, new markets, and AI updates we’re there as you grow