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This February 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report 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...
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This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions. Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report 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...
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ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...
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I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...
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Thus far, regulatory guidance for medical device cybersecurity has been focused on the approval or compliance of the device itself and has not been very specific about what cybersecurity assurance information is provided to the health care customers that host the devices within their IT infrastructure.  Medical device labeling has been sparse related to cybersecurity...
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Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...
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The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases – ultimately to raise public awareness of these unmet needs.  Let this motivate us all to explore, push limits, innovate, and invent.  Onward software...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator 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...
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For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...
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Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...
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Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator 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...
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Health Canada released the full guidance document, Pre-market Requirements for Medical Device Cybersecurity. It can be viewed at:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.htm It includes requirements such as: “Risk management is required for all medical devices throughout their life-cycle. Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are...
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This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. As more "software as a medical device" (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with...
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Another useful reference for establishing a safety culture in your software organization. “The purpose of this Handbook is to define the NASA Safety Culture Program and to provide guidance in the development and implementation—sustainment, growth, and practice—of Safety Culture at the Center level. It defines the NASA Safety Culture Model, describes the Safety Culture Survey...
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This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator 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...
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This 62304 Conformance Checklist Tool is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 62304 can provide an excellent framework from which to design a software process for medical device, medical mobile app, and/or HealthIT software.  62304 was created specifically for this type of software - it was not...
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Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.  Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019).  The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...
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Many years ago, Capers Jones, the software metrics guru, analyzed his database of thousands of software projects for the key factors affecting “real” software quality.  “Real” software quality relates to how the software actually performed and how robust in the field.   His list in priority order was: Programmer Application (domain) Experience Programmer Technical Experience Reuse...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...
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The West Australian reported that two autonomous haulage systems (AHS) trucks experienced a collision when one of the trucks backed into the cab of the second truck that was stationary at the time.  This is of interest to us as the AHS trucks are software controlled and they crashed.  Clearly a failure mode.  The initial report is...
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FDA issued a Safety Communication on January 31, 2019, (see Safety Communication Link) warning of the risk of air being introduced in a blood vessel (air-in-line) and air embolism for infusion pumps, fluid warmers, rapid infusers, and accessory devices.  This communication is directed toward users (both clinical and service personnel) and patients.  However, what can system architects,...
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Health Canada has recently provided a new approach for device approval as outlined in their “Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.” Canada classifies medical devices based on their potential risk, with Class I devices being lowest-risk and Class IV devices presenting the highest risk. The collaborative new approach aims to...
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The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems.  The idea is that the Verily watch would be worn similar (or as!) a consumer device...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software It appears that in response to a question posed by the IEC 62304 working group, the ISO and IEC member countries want ISO 14971 to be required for use of the second...
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Clearly one of the great struggles with medical device product design is to understand and finely tune the design input for our devices.  It is difficult but the payoff can be great when done well – pays off with development efficiency, greater certainty with safety risk control, and ultimately in customer satisfaction. In our training...
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It is always good to remind ourselves of exactly what the regulation says – often our corporate procedures can become “bloated” and lead some to believe that some specific activities and/or types of deliverables are required by the regulations.
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One of the most difficult challenges for medical device and HealthIT manufacturers is to properly "level" the design requirements for their medical device systems such that it is clear when it comes to design validation versus design verification.
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Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...
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Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
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Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304: Standards Navigator 62304 Ed2 Questionnaire
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A presentation on IEC 62304 Second Edition may be found at the following link: Standards Navigator 62304 Ed2 Presentation
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and regulatory activity overview Medical device software Two webinars were held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management and...
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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 recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Standards and Regulatory Activity Overview Medical device software Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health informatics, as well as the Member Bodies of ISO/TC 210, Quality management...
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The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...
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What concerns FDA when conducting a benefit-risk assessment of medical devices?  The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...
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Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...
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The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare.  There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians.  The FDA wants to regulate...
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Here is the report for June/July, 2018. SoftwareCPRStandardsNavigatorReportfor2018-07
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Prepared a visual aide (one of many we use in our training courses) of key Medical Devices Standards and FDA guidance related to software.  Enjoy! SoftwareCPR Sw Stds Guidances
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This update addresses International and US National medical device standards ("a view of the landscape") being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a...
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This content is only available to Premium level and Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11.  Portions could be made into handouts or provided electronically.  Download the manual...
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On Dec. 14, 2017, the FDA released a Draft guidance dated Dec. 15, 2017 “The Least Burdensome Provisions: Concept and Principles.” This guidance discusses FDA’s intent and approach to applying Least Burdensome Principles to the total product lifecycle for medical devices based on requirements in FDAMA (Public Law 105-115), the FDA Safety and Innovation Act...
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Summary of primary medical device standards as well as standards specific to Medical Device and Health IT software
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FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
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