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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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I don’t even really like to use the word retrospective
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A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors...
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Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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A security company indicated the following: … many companies received emails from Amazon indicating that their AWS S3 bucket policies were left configured as “publicly accessible”. These publicly accessible policies allow potentially sensitive cloud data exposed to cybersecurity threats, and likely are not the intention of the Amazon customers. Amazon recommended that each “bucket” policy...
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Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety.  Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar.  That concept is explained in relation to...
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This document provides Sherman Eagle's June 2017 standards status update to be used with the Standards Landscape document. It provides a summary of status updates to primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards.
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Cybersecurity firm Sophos published an article on Medical Device cybersecurity and David Overton of SoftwareCPR® suggested we post this as it may be of interest. David pointed out these statements: A significant percentage of medical devices are not secure. Most medical device manufacturers do not take serious steps to secure their devices for two reasons:...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Created a job aide which compares the IEC 62304 and IEC 82304 elements for requirements. This is only intended to be used as a starting point and requires interpretation based on knowledge of each standard and the type of...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Use this as a starting point to gather information on the software development environment (and related information) as required in FDA's Guidance for Software Information to be included in open market submissions. It is only intended as a starting...
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Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices. IEC TR...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety."  82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software as well...
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This content is only available to Standards Navigator and Standards Navigators PLUS subscribers.  See our Subscribe page for information on subscriptions. This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how...
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This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how the standards will impact the development of medical device and Health IT software. This is truly a MUST READ...
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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 Part 11 related warning letter excerpts included on this site as of the date above.  This file is updated periodically, but for the most recent warning letters between these updates, do text...
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This document is the result of an industry-led initiative of the European Commission. It is targeted at app developers and its purpose is to foster justified trust among users of mHealth apps which process personal data. Standards Navigator Draft Health Code of Conduct
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The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.
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Click here to view a summary of my highlights and rationale, along with some practical implementation tips for the new ISO 13485:2016:  SoftwareCPR-ISO13485 revision March 2016 highlights Some of the revisions add items included in FDA’s 21 CFR 820 Quality System Regulation such as Design Transfer, Validation of automation of quality system activities, detailed records, 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 a training aid that provides an overview comparison between the 2015 Amendment of IEC 62304 and FDA requirements based on 62304 Safety Classes. SCPRed_SoftwareCPR-FDA-62304SafetyClasscomparisonTrainingAide
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A sample checklist for releasing or updating software is at the link provided. GoLiveiChecklistTrainingExample111115
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/docs/scpred/standardsnavigator/SoftwareCPRStandardsNavigatorReport2015-1.pdf
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