MMI is committed to ensuring the highest standards of product safety and performance in compliance with EU MDR requirements. We ensure our organization meets the highest quality standards by integrating robust risk management, transparent reporting, and adherence to regulatory and legal guidelines into our day-to-day operations.
In compliance with MDR 745/2017 / Annex I / Chapter III/ Point 23.1, information relating to the Symani® Surgical System’s safety and performance is available below:
The Symani Surgical System is authorized for use in the U.S. by the FDA and is a CE marked medical device. Symani is manufactured in Pisa, Italy.
Clinical indications vary by geography. Refer to global indications for more information.
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