The AAMI Software Risk Management Technical Information Report draft comment period ended March 1, 2004. Comments were generally positive.The next step is a working group meeting May 11-12, 2004 to resolve comments and do a final edit to prepare the document for formal ballot. Contact one of the co-chairs if you are not a member...Read More

/docs/62304-446CD4comment0104.pdfRead More

The AAMI software committee is preparing comments on the “FDA Guidance for the Content of Premarket submissions for Software Contained in Medical Devices” in the interest of providing FDA input for future revision of this and related guidances. If you are not a member of the AAMI software committee and would like SoftwareCPR (a member...Read More

The AAMI Software Risk Management Technical Information Report working group has a full draft out for formal comment as of Jan 5, 2004. The comment period ends March 1, 2004. Contact one of the co-chairs if you are not a member of the AAMI committee and would like a copy for comment: Alan Kusinitz Managing...Read More

The AAMI Software Risk Management Technical Information Report working group has completed a full draft for committee and public comment. Contact one of the co-chairs if you are not a member of the AAMI committee and would like a copy for comment: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA...Read More

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The AAMI Software Risk Management Technical Information Report working group has issued a draft for comment to those interested in providing early informal feedback. Contact one of the co-chairs for more information: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA at pxj@fdadr.cdrh.gov.Read More

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This content is only available to Premium Level or higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA's software message and the role standards can play to benefit industry and...Read More

http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COPRead More

/docs/Trautman113485-0203.pdfRead More

http://www.itl.nist.gov/div898/strd/Read More

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http://hissa.nist.gov/effProject/handbook/c++/Read More

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FDA withdrew recognition of this standard in May 2007 after it was obsoleted and replaced by ISO 62304. On Jan 14, 2002 FDA issued an update to their list of recognized standards for use by the Office of Device Evaluation. A new software standard was recognized. This is the AAMI/ANSI SW 68 Medical Device Software...Read More

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Detail.CFM?STANDARD__IDENTIFICATION_NO=5188Read More

http://www.fda.gov/cdrh/ost/guidance/321.pdfRead More

/docs/NBRG_253-01.pdfRead More

/docs/AAMIFDAStandardsConference2001Summary.PDFRead More

http://www.ivthome.com/pdf/compstandards.pdfRead More

/Docs/UKDefenseSoftwareSafetyStd00-55Part1.pdfRead More

/Docs/UKDefenseSoftwareSafetyStd00-55Part2.pdfRead More

http://www.nrc.gov/NRC/NUREGS/SR0800/CH7/b14v15.htmRead More

/docs/MilitarySoftwareSafetyHandbookssshdbk.pdfRead More

Earlier this month FDA recognized UL 1998 for software. It followed up in the second half of the month by publishing new supplmentary information sheets for all recognized software standards that explains the recognition and how each could be used to reduce software documentation in submissions. Subscribers to SoftwareCPR.com can login, go to the Library...Read More

/Docs/sw68cdv-roc3.PDFRead More

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With the permission of AAMI attached is a pdf of the AAMI newsletter article summarizing the software session of the March 2000 International Software Standards Conference. AAMI 300 software articleRead More

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FDA CDRH Office of Device Evaluation standards recognition statement for ” IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements For safety; 4. Collateral Standard: Programmable electrical medical systems”. FDA did not choose to recognize this standard for software submissions or even outright for risk management. They did issue a recognition statement explaining their...Read More

“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store...Read More

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