Day

May 27, 2015
VUAB Pharma a.s..Product: pharmaceutical manufacturing facility Date: 5/27/2015 ailure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions. Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of (b)(4), API. Specifically, our inspection revealed your firm did not...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DuraDiagnost X- Ray Recall Number Z-1555-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DigitalDiagnost System X-Ray Recall Number Z-1554-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....
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Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591...
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Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1)...
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Company: Baxter Corporation Englewood Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. Recall Number Z-1628-2015 REASON Baxter Corporation is conducting a field action for...
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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

Need info?  Email us at training@softwarecpr.com

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