Expert QA & RA Consulting for Medical Device Software

MedQR – QA & RA Consulting

Welcome at MedQR Consulting B.V.
At MedQR Consulting we offer regulatory and quality consultancy support for medical device industry. This includes existing product portfolio’s as well as MedTech start-ups. The regulatory path towards market approval can be complex and dynamic. A strategic approach to bring your products to market from a compliance as well as a business perspective. Our highly skilled and experienced team can guide you through the medical device regulatory playing field.

Together with you we will pave the way for sustainable and continuous compliance. Coaching, educating and building your RA/QA team, to empower you with the latest knowledge and skills.

A better experience

We take the time to understand your product, your company, and your goals. This way, we can offer advice that really fits your situation—not just standard solutions. Every MedTech journey is different, and we’re here to support you every step of the way.

Our services cover the full product lifecycle. From early development to market approval and beyond.

At MedQR Consulting, we keep things simple, clear, and focused. We want to make compliance easier for you, so you can focus on growing your business with confidence.

Quality Assurance

Quality assurance (QA) is the backbone of each medical device legal manufacturer. With a solid quality management system (QMS), that complies with the requirements of ISO13485 you will be able to bring your device to market and comply with regulatory requirements.

Regulatory Affairs

Regulatory affairs (RA) means to us; all topics related to medical device regulation compliance. The regulatory path is complex and dynamic. MedQR Consulting BV offers full scope regulatory affairs support to guide your business bringing innovations to market or maintaining regulatory compliance of your product.

Free consult

Book a free 30-minute consult with one of our QA/RA experts to discuss your needs and challenges. In this short call, we can:
It’s a no-obligation chat to see how we can support you—schedule your free consult today!