Clinical evaluation.
Done right.
Our mission is to help MedTech innovators bring safe, compliant products to market by simplifying EU MDR requirements.
CERs, post-market reporting, gap assessments.
No fluff, just airtight regulatory writing that holds up.
Meet Marysa
Owner/Consultant
Marysa Mezzetti is the owner Mezzetti Consulting, a consulting company specializing in EU clinical and regulatory strategy for medical devices. She brings a track record of guiding companies through complex EU MDR clinical requirements, and establishing compliant procedures with long-term solutions.
With more than eight years of experience in Clinical Evaluation Reports (CERs), Marysa has authored over 200 CERs across a range of device type, risk class, and therapeutic areas. Beyond report writing, she has built and implemented new clinical evaluation systems for manufacturers, which includes training internal teams to the new compliant procedures.
Marysa collaboratively partners with medical device manufacturers to simplify the path to compliance. She combines technical expertise with a practical, approachable perspective, helping clients not only meet regulatory expectations but be able to focus their efforts on innovating rather than documentation.
Our Services
From first CER to ongoing PMS, we handle the clinical writing so you can focus on the device.
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Telling your clinical story – Executing clinical evaluation plans and reports to provide regulators with an easy-to-follow evaluation of if the product is safe and effective. May include executing clinical gap assessments driving remediation.
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Creating clinical evidence road maps – developing a plan to ensure your product has sufficient clinical evidence to demonstrate performance and safety or to support marketing claims. Includes executing PMCF Plan and Reports.
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Tracking safety – developing a plan of how the device will be followed throughout its time on the EU market and executing the reports per regulations. Includes writing PSURs and performing post market literature searches.
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Providing Guidance - EU MDR guidance regarding clinical justification of validation tests, clinical claims, document project management, and more.
Contact Us
Interested in working together? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!
You can also contact us at Marysa@MezzettiConsulting.com