Our group of former-Notified-Body-employed experts collectively bring the benefits of over 24 years of Tier-1 EU Medical Device Notified Body work experience on a wide variety of medical devices ranging from Class III Implants in Vascular, Orthopedics, and Spine along with class III 'combination-products' aswell as class IIb devices. Our experts were selected to work at these EU Notified Bodies because of their deep product development experience on a wide variety of medical devices. Our Notified-Body-trained experts collectively bring more than 25 years of New Product Development Engineering expertise having worked for some of the largest and most successful global Med-Tech companies in the world.

 

While employed by Notified Bodies, we have collectively performed over 300?? conformity assesments - so we know, first hand, what EU Notified Bodies are looking for! In industry, our experts have cumulatively authored over 413 Clinical Evaluation Reports (CERs). Based on the cumulative career expereince of our experts, we are exceedingly well-trained and poised to handle any issue related to EU MDR submissions from, Gap Analysis, preparation for EU MDR QMS certification, mock-audit, submission preparation (partial or full), Clinical Evaluation Reoirts, Post Market Clinical Follow-Up and everything in between. Our experts are all highly acoladed engineers who are are experts in new product development with many successful product launches under their belt. It is the UNIQUE INTERSECTION of these SKILL SETS that SETS US APART. Our expertise at Pathway Med-Device Advisors International can be utilized and harnessed to proactively maximize your chances of CE Mark certification via our proactive gap analysis advisory process and submission writing services.

 

Feel free to get in touch with one of Pathways EU MDR experts in a convienient method of your choosing (free 30 minute consultation, text or immediate* call back - if your situtation requires urgent attention. Please feel free to contact us today to learn more about our documented track record of success with EU Notified Bodies and to discuss HOW WE CAN HELP get you and your company to the next regulatory milestone to achieve your regulatory goals with maximum urgency and efficiency.