November 25, 2020
Company: Mako Surgical Corporation Date of Enforcement Report: 11/25/2020 Class II PRODUCT Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 – Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register...
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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 Recall Number: Z-0461-2021 REASON Potential incorrect validation of results due to...
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Company: LivaNova USA Inc Date of Enforcement Report: 11/25/2020 Class II PRODUCT VNS Therapy AspireSR Generator Recall Number: Z-0462-2021 REASON Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. RECALLING FIRM/MANUFACTURER LivaNova USA Inc...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Recall Number: Z-0473-2021 REASON Test Definition scanning may reset custom settings to defaults causing falsely low or...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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