December 30, 2020
Company: B Braun Medical, Inc. Date of Enforcement Report: 12/30/2020 Class II PRODUCT APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 – Product Usage: intended for intravascular administration to a patient. Recall Number: Z-0717-2021 REASON There is the potential for the compounding system to not immediately interrupt compounding and alert user to...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 12/30/2020 Class II PRODUCT Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) – Product Usage: intended to be used for the controlled administration of fluids. Recall Number: Z-0712-2021 REASON There is a potential software error during programming. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 11/23/2020....
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Company: Haag-Streit USA Inc Date of Enforcement Report: 12/30/2020 Class II PRODUCT Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615...
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62304 Public Training Course DATES:  February 23-25, 2021 Clock time each day TBD COST: 3 Full Days for $2,100.00 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software, including FDA expectations for software and alignment with 62304, and much more. The course compares and contrasts 62304 with...
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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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