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The IEC 62304 is also pretty clear when it comes to software architecture: The standard prohibits ad-hoc design decisions. Of course, capable software architects can develop and revise a software architecture iteratively and document it in compliance with standards.

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Compliance to the Regulations. If navigating between the FDA guidance documents and IEC 62304 is a difficult task, figuring out the differences is downright ominous. They have much in common, but they use different terms and definitions to get their point across. IEC 62304:2006 is currently a recognised standard, and represents an accepted approach to the software development process for medical devices. China China Food and Drug Administration (CFDA) The IEC 62304:2006 had been translated into China industry standard: YY/T 0664-2008 equally and implement from 2009.6.1, it BS EN 62304:2006+A1:2015: Title: Medical device software. Software life-cycle processes: Status: Current, Work in hand: Publication Date: 30 November 2006: Normative References(Required to achieve compliance to this standard) EN ISO 14971:2000, ISO 14971: Informative References(Provided for Information) IEC-62304 IEC 62304:2006 Checklist A. General Requirements Quality management system Risk management Software safety classification B. Software development process Software development planning Software requirements analysis Software architecural design Sofware detailed design Software unit implementation and verification Software integration and integration testing Software system testing Get 62304-2 Splices specs, pricing, inventory availability, and more from TE Connectivity.

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2016-10-01

DIREKTIV om harmonisering av lagstiftningen i medlemsstaterna rörande att göra radioutrustning tillgänglig  Developing IEC 62304 compliant software for medical devices is not a trivial thing. You have to develop software in line with its intended use and compliant with  Medical device software — Software life-cycle processes (IEC 62304:2006) för medicinskt bruk – Livscykelprocesser för programvara (IEC 62304:2006). 2 Lediga 62304 jobb i Göteborg på Indeed.com.

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However, if this seems like too much regulatory work, feel free to … 2015-04-30 The IEC 62304 requires you to document your Software Architecture. As always, the standard doesn’t provide many details on how you should actually do that. This is good and bad: You can do it however you like, but nobody’s going to tell you how to do it. 17 rows 2020-10-30 EN 62304:2006 - Frequently Asked Questions Page 9 2 Questions and Answers 2.1 Scope of EN 62304 2.1.1 Does EN 62304 relate to only the MDD (93/42/EEC)?

The processes put forth by IEC 62304 are really established best practices in the software industry, most of which can be followed for both medical and non-medical projects. The standard does not prescribe a particular life cycle model or documentation structure, only that the activities and tasks be completed. IEC 62304 Safety Classes As the standard states, "The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD (being a potential source of Harm) to which the SOFTWARE SYSTEM can contribute." IEC 62304 is an international standard medical device software that defines an agreed upon framework for processes that occur throughout the product lifecycle.
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IEC 62304 must be applied in conjunction with ISO 13485 standard which offers a framework for the lifecycle processes necessary for the safe design, risk analysis, version control and maintenance of standalone software.

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