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October 29, 2021
Company: Zimmer Biomet Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
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“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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