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MedQAIR is your partner in regulatory compliance. We support organisations with their regulatory strategies, quality and information security management systems, risk assessments, clinical evaluations, cybersecurity, and other technical documents. Our MDIS platform streamlines compliance across the full economic operator chain, including manufacturers, importers, distributors and authorised representatives. With decades of experience, we’ve supported market access across the EU, US, and beyond, including high-risk and AI/ML-enabled medical devices. We're here to guide you along the complex regulatory pathway.
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We had an amazing experience collaborating with Medqair on our ISO 13485 QMS audit and the Technical Documentation review for a Class IIa medical device. They joined at a later stage, when we were facing a regulatory bottleneck and looking for answers. They adapted quickly to an ongoing process and, frankly, saved the situation.
We had the pleasure of working with MedQair to achieve two critical certifications for our business — ISO 27001, which we obtained in just six months, and subsequently ISO 13485. Their team proved to be extremely efficient, highly collaborative, and consistently dependable throughout the entire process. MedQair’s structured approach and hands-on support made a complex journey feel smooth and achievable. We greatly value their partnership and would wholeheartedly recommend them to any company aiming for rigorous compliance and quality standards.
Ivo and Leon from MedQAIR were a huge help in getting us ISO 27001 certified really quickly. They really know their stuff when it comes to medical devices, medical software, and (cyber)security. Super professional but also easy to work with — they made the whole process very smooth. Would definitely recommend them if you're in the medical field and need help with certifications.
Ivo and Leon provided indispensable guidance and support on formulating and evidencing our project teams management of the Security risks of our product in order to submit for FDA submission. Their subject knowledge, experience, diligence and all round service professionalism were excellent and very influential on our successful approval. Their combination of talents and experience complement each other well providing broad, practical and objective advice and direction. They are flexible, responsive in their availability and delivery and transparent regarding budgets and invoicing. I am very much looking forward to working with them again.
Working with everyone at MedQAIR is a delight. Their deep understanding of the regulatory landscape and unwavering support has helped us tremendously to elevate our whole QMS. Highly recommended!
We worked with Leon Doorn of MedQair on our ISO 27001 and NEN7510 certification in 2024. Leon was instrumental in developing our certification strategy and execution and presented as a true colleague in our team. Well done! We continue to work with MedQair for our ongoing regulatory and compliance efforts.
Bilihome worked together with the team of MedQAIR on our cybersecurity. The team was highly competent, flexible, and really helped us and move forward with their knowledge.
MedQAIR are an extremely knowledgable, and skillful company that is able to translate complex legislation into workable, practical procedures. They've helped us turn around a multi-year dragging process with another consultant into getting the ISO 13485 certificate in less than nine months (and now just waiting for the final approval on our CE-MDR class IIb certificate). We have been working with Leon over a year and Ivo over six months and we could not be more happy with their work. Without MedQAIR this would never be possible.
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