Software in Medical Devices, by MD101 Consulting

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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...

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