At Pathway Medical Device Advisors International, our team of Notified Body experts offer over 25 years of combined experience working for Tier-1 EU Notified Bodies across a wide variety of medical devices, including class III implants in Vascular, Orthopedics, Spine, and combination products, as well as a wide variety of class IIa and class IIb devices. Our experts were selected and hired by these these Tier-1 Notified Bodies due to their extensive product development experience and deep understanding of the medical devices in their domains of expertise.

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With more than an  additional combined 25 years of expertise in New Product Development Engineering, our experts have worked for some of the largest and most successful global medical device companies. During our time working for EU Notified Bodies, we have collectively performed over 300 EU class III CE-Mark certification conformity assessments, gaining invaluable training and insider-insights into what EU Notified Bodies  require for successful submissions.

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In addition, while working in the device industry, our experts have authored over 413 Clinical Evaluation Reports (CERs), demonstrating their proficiency in navigating the regulatory complexities of medical device approval in Europe and Australia. We are highly skilled in all aspects of EU MDR submissions, including gap analysis, EU MDR QMS certification preparation, mock audits, submission preparation (partial or full), Clinical Evaluation Reports, and Post Market Clinical Follow-Up.

 

The unique intersection of our deep product development expertise, former Notified Body employment, training, and hands-on experience is what sets us apart. Pathway Medical Device Advisors International is uniquely positioned to help maximize your chances of CE Mark certification and with minimal questions from the Notified Body. Through our proactive gap analysis and tailored submission services, we ensure that you are well-prepared for a successful EU MDR submission. We offer a 30-minute complimentary consultation.

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Feel free to get in touch with one of Pathway's EU MDR experts in a simple, convenient, and hassle-free method of your choosing (free 30-minute consultation, text or immediate* call back - if your situation 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 TGA to discuss HOW WE CAN HELP get you and your company to the next regulatory milestone achieving your regulatory goals with maximum urgency and efficiency.