By

Alan Kusinitz
/docs/ASQBiomedicalDivisionPart11comments.PDF
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/Docs/SCPRed/OperationalControlsSlide.pdf
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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 article
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At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...
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The Drug GMPs explicitly require signatures in the following places: 211.186 master prod & control recs 211.182 Equipment cleaning & use logs 211.188 batch prod & control recs 211.194 laboratory recs (perform & review) Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where...
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The Medical Device and Diagnositc Industry periodical occassionally prints software articles oriented to Medical Device Manufacturers. To see their index of these articles by year, view the following link: MDDI Software Articles
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Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...
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Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used. Its...
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The New England Biomedical Discussion Group held a half-day seminar on Risk Management. Alan Kusinitz of SoftwareCPR gave a presentation on Software Risk Management. The newsletter summary of the seminar is at the link provided: Intro to Risk Management Article
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“A Software Development Process Model for Artificial Neural Networks in Critical Applications” by David M. Rodvold Colorado Technical University and Xaim Inc.presented at the International Joint Conference on Neural Networks (IJCNN’99). Washington D.C. July 1999. In this paper Mr. Rodvold addresses the challenges of using neural networks in critical applications and describes an approach to...
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/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdf
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“Capability Maturity Mode Implementation and Risks” byTracey Briscoe of Quality Systems and Software (maker of the DOORS requirements management tool).This white paper provides a concise overview of the CMM and some common issues regarding its value, costs, and implementation approach. Quality Systems and Software has a variety of white papers and courses offered on its...
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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...
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