Day

October 29, 2021
29
Oct

Recall – Major robotic surgery platform software error

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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29
Oct

Recall – ROSA One 3.1 Cl

October 29, 2021
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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29
Oct

FY2022 SW Related Guidance

October 29, 2021,
“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significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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