December 23, 2020
Company: Medtronic Neuromodulation Date of Enforcement Report: 12/23/2020 Class II PRODUCT Percept PC Implantable Neurostimulator (INS) – Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. Recall Number: Z-0612-2021 REASON A software anomaly...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 12/23/2020 Class II PRODUCT RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7,...
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Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 12/23/2020 Class II PRODUCT Tempus LS – Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 – Product Usage: The device is intended to be used in the following environmental: – Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). Recall Number:...
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Company: Kowa Optimed Inc Date of Enforcement Report: 12/23/2020 Class II PRODUCT Kowa VK-2s software Version, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras – Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. Recall Number: Z-0636-2021 REASON It has been determined...
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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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