By

Alan Kusinitz
/docs/FDApremarketReviewCommunicationsGuidance040414.pdf
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The Director, Office of Policy and Planning, of the Office of the National Coordinator for Health Information Technology provided an overview presentation on ONC’s perspective on the FDASIA draft report. The slides are at the following link: FDASIA-HITDraftReportOverview0414 As with all presentations SoftwareCPR reminds readers to refer to the actual source documentation, in this case the...
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The FDA released its anticpated draft report on regulation of Health IT. This report includes a risk-based regulatory framework for health information technology (health IT) that is a step towards clarifying what software will be actively regulated by FDA. The report was developed by the U.S. Food and Drug Administration in coordination with the Health...
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The Wall Street Journal reports that “the top federal auto-safety regulator will defend his agency before Congress on Tuesday, telling lawmakers that General Motors had “critical information” that would have helped it identify a defect earlier in the Chevrolet Cobalt and other vehicles and might have changed the agency?s course in investigating the problems.In prepared...
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In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...
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In a new draft guidance (for electrosurgical devices but in our opinion representative of information needed for other devices) FDA stated that cybersecuirty information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm383206.htm#s5
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The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010
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The Office of National Coordinator for Health Information Technology published a proposed rule for Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements. The proposed rule eliminates the “complete EHR” designation, separates the content and transport certification criteria and announces a more frequent certification rule making process. The proposed rule also...
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There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include: A requirement for a risk management process has been added in the product realization phase and ISO 14971...
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AAMI recently published “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” in Biomedical Instrumentation & Technology (BI&T). The article reports on an actual hospital network/health IT assessment using 80001-1 as one of the tools for the assessment.
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Sherman Eagles of SoftwareCPR co-authored AAMI’s recently published article “Reducing Risks and Recalls: Safety Assurance Cases For Medical Devices” in the January/February 2014 issue of BI&T (Biomedical Instrumentation & Technology; a monthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation). The full article is posted with permission at the link provided. Any...
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The latest ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided: Mars Code February 2014
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A new set of guides and interactive tools to help health care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at the link provided. The Office of the National Coordinator for Health Information Technology (ONC) at HHS released the Safety Assurance Factors for EHR Resilience...
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NIST received comments on the Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity and is updating the framework. They have announced that the final version (Version 1.0) will be released on February 13. When it is released, the Final Framework will be posted at NIST.
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http://www.aami.org/news/2014/020514_FDA_Overhaul_Inspection_Compliance_Activities.html
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The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...
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SoftwareCPR comments on common confusion: Struggling with Essential Requirements? Many manufacturers faced with compliance to the 3rd edition of 60601-1 do not understand which of their product requirements meet the essential requirements definition. Confusion arises over the actual risk control measures designed into the system and the requirements for the “performance of a clinical function...
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http://www.ibm.com/developerworks/library/j-fuzztest/index.html
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http://wallstcheatsheet.com/stocks/more-apple-iwatch-clues-fda-meeting-and-healthbook-app.html
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http://www.aami.org/news/2014/011514_FDA_Names_Issuing_Agencies_for_UDI.html
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Lisa Simone, a biomedical software engineer at FDA, published an article in the Biomedical Instrumentation & Technology Journal (Nov-Dec 2013) with information on an analysis of historical software related recalls using internal information at FDA as well as other sources. The article breaks down the recalls by year and product type. She investigated the years...
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The International Telecommunication Union (ITU) has adopted the Continua Design Guidelines (CDG) that contain specifications to ensure the interoperability of devices used for applications monitoring personal health (Recommendation ITU-T H.810 Interoperability design guidelines for personal health systems). ITU-T H.810 is available at the link provided: http://www.itu.int/rec/T-REC-H.810-201312-I
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The Association for the Advancement of Medical Instrumentation selected Alan Kusinitz (Managing Partner of SoftwareCPR) to join its board member nominating committee. Alan has contributed to standards development and training programs for AAMI over many years in the interest of protecting public health.
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http://www.nist.gov/itl/upload/preliminary-cybersecurity-framework.pdf
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The U.S. Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) maintains a website at the link provided. This website includes information and updates on Health IT and Electronic Medical Records programs for software that often is not considered a Medical Device and not regulated by the U.S. FDA.
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IECEE published Document OD-2044 Ed. 2.2, Evaluation of Risks Management in medical electrical equipment according to IEC 60601-1 and IEC/ISO 80601-1. The procedure intends to provide a uniform approach to the Certification Body Testing Laboratory and Manufacturer on assessment and documentation of compliance with the relevant clauses of IEC 60601 standard series related to the...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains all software and computer related warning letter excerpts included on this site. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This compilation is provided...
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AAMI announced that TIR45-2012 “Guidance on the use of agile practices in the development of medical device software” was their most popular TIR for 2013. This document was developed with the participation of FDA and addresses how Agile Methods can be use in compliance with FDA medical device regulations for software. Brian Pate and Alan...
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http://in.reuters.com/article/2013/12/18/cyberattack-fda-drugmakers-idINDEE9BH00N20131218
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The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD def
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http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/
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The document at the link provided is a short checklist for helping ensure or assess requirements quality. It is an educational aid to be used only by knowledgeable individuals and should not be used blindly or considered comprehensive. This was prepared by Brian Pate with input from Alan Kusinitz. Requirement Quality Checklist
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FDA’s Device Center added a dedicated webpage on Cybersecurity for medical devices in its connected health section.
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
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Oct 22, 2013 press release from the office of Conressman Marsha Blackburn:”Congressman Marsha Blackburn (R-TN07) joined Representatives Gene Green (D-TX29), Dr. Phil Gingrey (R-GA11), Diana DeGette (D-CO01), Greg Walden (R-OR02), and G. K. Butterfield (D-NC01) today in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile...
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This SoftwareCPR.com newsletter lists items added to the website from 7/22/2013 to 10/24/2013. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and the related web page should...
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The amendments to ISO 62366 and IEC 60601-1-6 were approved unanimously. The amendment to 62366 introduces requirements for legacy products that were created prior to the adoption of ISO 62366 and the amendment to 60601-1-6 clarifies the elements of the usability engineering process that are required for compliance with the IEC 60601 series
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If sample sizes need to be determined there are many statistical methods and assumptions related to this so decisions should be carefully considered. Two of the most commonly used sample tables are ISO 2859 for attibutes and ISO 3951 for variables.
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