March 14, 2018
This content is only available to Premium level and Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11.  Portions could be made into handouts or provided electronically.  Download the manual...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/14/2018 Class lI: PRODUCT Philips Network Firewall (Cisco ASA 5506)Product Usage:The Cisco ASA 5506-X provides IPv4 and IPv6 Routing and Network Address Translation (NAT) capabilities. It also provides the following: Port Filtering Stateful Packet Inspection Default Protection Policies These default policies trust all outgoing traffic and...
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Company:Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 3/14/2018 Class lI: PRODUCT A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient...
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Company:Medtronic Navigation, Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4)...
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Company:Abbott Point Of Care Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) Recall Number Z-0946-2018 REASON Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action...
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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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