September 23, 2020
Company: Life Technologies Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens...
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Company: Medtronic Inc. Date of Enforcement Report: 9/23/2020 Class II PRODUCT The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device. Recall Number: Z-2980-2020 REASON As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous...
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Company: Novarad Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. Recall Number: Z-2956-2020 REASON The firm received a report of an atypical...
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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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