Software in Medical Devices, by MD101 Consulting

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Friday, 12 January 2018

Consequences of the 21st Century Cures Act - State of Play

Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.

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Friday, 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

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Friday, 17 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability

In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).

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Wednesday, 25 September 2013

FDA issues final Mobile Medical Apps Guidance

After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!

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Friday, 13 July 2012

Happtique App Certification Program

Happtique, an appstore for mobile medical devices has drafted an App Certification Program.
This not a program or a process but a list of functional and non functional requirements that mobile health apps should respect to be certified - according to Happtique. It' a bit like the requirements of Apple to be authorized to place an app in the Apple Store. Happtique publishes your app on its store if you are compliant with its certification program.
There is a lot of work behind this document, and a lot of knowledge. However I don't think this is enough to make a certification program. This document focuses on the results, whereas all software development standards focus on the processes. FDA focuses also on the processes when its auditors verify compliance to 21.CFR.
In the scale of precedence of documents, I would put it here:

  1. Legal (choose your country): 21.CFR, 92/42 EEC (essential requirements), CMDCAS, ANVISA, KFDA...
  2. Medical devices general standards ISO 13485 and ISO 14971
  3. Software development standards: IEC 62304, IEC 60601-1, and the like
  4. Guidances: GPSV, IEC/TR 80002-1, ISO/TS 14969
  5. Generic functional and non functional requirements: Happtique App Certification Program.

It's obvious that Happtique wants to make some noise with its certification program (and it has reached his goal, you're reading this post). But I have to recognize that this document contains a big source of information for software requirements. The content of this certification program is a perfect source of ideas to write a software requirements specification (SRS).

The world of mHealth is moving fast. In the same kind of article, I have found Tech Barbarians at the Medtech Gates, this article is a good summary of antagonist forces at stake. On the one hand, the regulators and their, so called, ante-Flood rules. On the other hand, the software industry with its new world of mHealth. Guess who's going to have the last word? If, like me, you don't have the answer, continue to apply the standards and regulations...

Friday, 6 April 2012

Inflation of software medical devices - part 3

This article is the last of three articles which deal with the concept of "inflation" of medical devices. The first one was on inflation of standards, the second about inflation of regulations. This one, the most interesting to my eyes, is about multiplication of apps on mobile devices, especially smartphones and tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical" categories of the Apple or Android appstores. Many of these apps are classified as medical devices and are in the scope of regulations like FDA and CE Mark. Note that some apps may be regulated the FDA but not the CE Mark or vice-versa.

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Thursday, 5 January 2012

Pfizer recalls Rheumatology Calculator smartphone App

Dozens of companies recall their medical devices every month. A recall happens when something wrong happened with the device, like a bad labeling or a bad sterilization. It's the responsibility of the manufacturer to warn ALL their customers and the government agencies that a given lot or batch of products has a defect. The batches shall be destroyed or sent back to the manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone app used to compute a score to assess the desease of patients according to complex algorithms. There is a bug in the app and it gives wrong results.

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Monday, 14 November 2011

iPhone and Android applications are mobile medical devices

The boom of mobile apps on smart phones clearly impacts the medical devices industry. Doctors are eager to have the last software gadget (the app) on their hardware gadget (the smartphone, the tablet). As a result, many apps on Apple Store and Android Store fall into the scope of medical devices: terminal to remotely display medical images, apps to compute doses of medicines, an so on ... The list is long.

And gess what? These apps shall be certified before being put in the Apple-Android stores. The FDA is clear about these "mobile medical apps" in a draft guidance published in july 2011: "For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification." see the Draft Guidance. For the CE mark, the rule is the same, mobile medical apps fall into the category of active medical devices.

The big family of medical devices is getting more and more children. Welcome to the baby smartphone apps!