By

Alan Kusinitz
/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf
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FDA has created a webpage dedicated to regulation of Medical Device Data Systems. Note that the deadline for registration and listing (including for healthcare institutions that would be considered MDDS manufacturers) is May 18, 2011, and the deadline for reporting adverse events through MedWatch is April 18, 2012.
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The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CD
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A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.
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The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software.  In some instances it is more specific than FDA requirements.  The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June...
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There is a specific standard for radiotherapy treatment planning systems, IEC 62083 Edition 2.0 (2009-09-23) Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems. When there is a specific standard, it takes precedent over general standards. IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone...
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IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone product does not fall within the scope of IEC 60601-1. A new work item on Healthcare Software Systems was recently approved. This new standard is intended to apply to stand alone software and will have similar (but not necessarily the...
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FDA issued a new list of recognized standards. This includes withdrawal of recognition of the previous version and recognition of: “12-218 NEMA PS 3.1–3.18 Withdrawn and replaced with newer version (2009) Digital Imaging and Communications in Medicine (DICOM) Set.”
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MASSDEVICE reported that “At a Food & Drug Administration town hall meeting held March 10 in Irving, Texas, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed … that the agency plans to issue guidance on mobile medical applications later this year.”
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Health Canada published a notice entitled “Software Regulated as a Class I or Class II Medical device,” along with a Q&A memo to clarify what software is regulated and which regulations apply. Both documents are included at the link provided. The notice appears to indicate that any software which fits the definition of a medical...
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The document at the link provided is a brochure describing the Standards Navigator subscription options. Subscribing keeps you abreast of Heath IT and Medical Device software standards development, interpretation, and application. Standards Navigator Benefits  
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This topic provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.Draft standards are posted...
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The pdf at the link provided is a reprint of an article in the November 2010 issue of the Jounal of Medical Device Regulation entitled “US Medical Device Software Regulation”. This article was authored by Sherman Eagles, and Alan Kusinitz, Partners at SoftwareCPR.  The article provides an overview of FDA regulations related software distributed in...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains a training template used in SoftwareCPR training on production and quality system software validation. It presents a general validation form for discussion that can be used itself for simple applications or tools...
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/docs/MammographyGuidanceAddendum111610-UCM185904.pdf
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This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains selected templates used in SoftwareCPR training on medical device software standards focused on IEC 62304. These are not intended to be ideal for all situations or comprehensive but are intended to serve...
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http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htm
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Slides from a presentation by Molly Ray of SoftwareCPR are at the link provided as a pdf. These slides provide an introduction to pre-market submissions for devices that are, or contain, software. SoftwareCPR Presentation-510k
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The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. Agile For Medical Devices-SoftwareCPR Presentation
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At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.
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http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm
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The link provided is to a NASA website on software development, V&V, quality and safety assurance. There are links to many software checklists that may relevant or a starting point for tailoring for medical device software. There is also a link to the 1997 NASA software safety standard from their website. NASA Software Assurance Website
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http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm081667.pdf
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Recipient: OptoviIe, Inc.. Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB) Date: 6/11/10 Our inspection revealed your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C....
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This SoftwareCPR.com newsletter lists items added to the website from Nov 9, 2009 to May 19, 2010 . 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...
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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http://www.massdevice.com/blogs/massdevice/medical-devices-next-hackers-target-list
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CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...
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CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...
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Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....
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Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:...
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. Subsequently HHS issued a series of educational documents regarding various aspects of the rule including administrative controls, physical controls, technical safeguards, risk management and others.  
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Company: Sunrise Pharmaceutical, Inc Date: 1/14/10 Product: Pharmaceuticals Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example, your firm lacks systems to ensure that all electronic data generated...
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At the link provided is a paper issued in April 2008 by the Australian Department of Defense entitled: “Dependability of Software in Airborne Mission Systems”. It contains a useful list and description of software related standards outside the medical device industry that may be helpful in medical device software development and risk management. AUS SW...
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The link provided is for “42 CFR Parts 412, et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule.” 42CFR_412_EHR_HITECH
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In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...
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