Our Offerings
Medical Devices CE Marking
Navigate the European Medical Devices Registration Process with Expert Support.
At AZB Consulting, we specialize in guiding companies through the complex process of Medical Devices registration in Europe. Whether you are introducing a new product or expanding your portfolio, our experts provide customized, strategic support to secure timely and successful CE marking across the Notified Bodies and Health Authorities.
Our deep regulatory intelligence, combined with extensive hands-on experience with the Notified Bodies and national competent authorities, ensures a proactive, efficient, and compliant path to grant the CE marking according to MDR 2017/745.
Our services include regulatory strategy, writing of the Technical Documentation according to current requirements, submission planning &, support with your notified body, risk assessments, gap analysis and due diligence. We provide advice to ensure you’re always one step ahead of regulatory expectations.
Our Expertise
At AZB Consulting, we offer a comprehensive suite of regulatory services to guide your product through successful registration in Europe.
We provide strategic and operational expertise to streamline your product’s journey to grant your CE Marking across Europe, Switzerland, and the United Kingdom.
Registration Strategy
We design customized regulatory strategies that align with your product’s development stage and commercialization goals. Our experts build efficient roadmaps, to optimize your pathway to the CE Marking across the European Union, Switzerland (via Swissmedic) and the United Kingdom.
Technical Documentation Writing
We manage document writing of all relevant sections of the dossier, submission-ready Technical Documentation that meet the rigorous standards of MDR 2017/745 and Notified Bodies, ensuring your submission is complete and compliant. We publish and submit the dossier following your Notified Body requirements.
Management of Registration Procedures
We manage all aspects of the registration process, supporting your company to manage questions received from the Notified Body.