Marysa Mezzetti is the owner Mezzetti Consulting, specializing in EU clinical and regulatory strategy for medical devices. She has spent nine years guiding manufacturers through EU MDR clinical requirements, with a focus on procedures that hold up to notified body scrutiny. For years she has been leading process change for her clients to reduce notified body review time and get products to the EU market faster.  

She has authored more than 200 Clinical Evaluation Reports across device types, risk classes, and therapeutic areas. Her therapeutic areas of most experience are orthopedic implants and minimally invasive cardiovascular products. Beyond writing CERs, she has built clinical evaluation systems from the ground up for manufacturers, including training internal teams to run them independently.

Marysa works directly with manufacturers to simplify the path to compliance by combining regulatory depth with a practical, hands-on style, so clients can spend less time on documentation and more on the product itself.