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Timely, insightful, and relevant thoughts, opinions, and discussion on FDA software validation, 62304 compliance, medical device software standards, updates impacting medical device and HealthIT software development, and sundry subjects from our Partners and staff.

This 62304 Conformance Checklist Tool is typically only available to Premium and higher subscribers, but is being made available to all on our website.  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...
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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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