RA Consulting

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. Our consultants have full scope knowledge and experience with the implementation of the EU-MDR. For access to the US market, the MedQR team is also happy to help understanding your path towards FDA clearance. 

Whether you are a start-up company  facing regulatory compliance for the first time, or an existing company going through MDR transition. We can help you toward the best compliance and business decisions.

Our team is very hands-on, we are not just explaining or involved in strategy determination. We can support technical documentation writing as well as notified body submission. Regulatory writing is a skill that requires experience. Together with your team we make sure we speak the right language.