Software in Medical Devices, by MD101 Consulting

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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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Friday 3 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless

In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.

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Friday 15 November 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

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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 2 August 2013

FDA Mobile Medical App Guidances should be released by the end of the year

To continue the topic about FDA draft guidances related to software and information systems, the FDA put in its top list the release of the Guidance of Mobile Medical Apps.

Guidance of Mobile Medical Apps is in the "A-list" of FDA and should be released by the end of 2013.

In hot topics, we have also a warning letter sent by the FDA to Biosense Technologies. The mobile App named uChek Urine Analyzer and developed by Biosense Technologies, falls into the category of medical devices, says FDA. Biosense claims on its website that the App turns the smartphone into a medical lab.

With such claim, it's not surprising that the FDA wants Biosense to submit a 510k!

Friday 12 July 2013

Unique Device Identification for software medical device - part 1

Unique Device Identification (UDI) had been in the pipes of regulators for a few years, beginning with the US in 2007, and following (as usual) by the European Union a few years later in 2012.
In parallel, the International Medical Device Regulators Forum (IMDRF) issued in 2011 a guidance on UDI, with the honorable objective of harmonizing UDI's all over the world.
What is the impact of these regulations and guidances on medical device software?

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Friday 22 March 2013

EU Guidances - What's new?

A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.

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Friday 8 March 2013

How to bring legacy software into line with IEC 62304? - part 3

We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.

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Friday 8 February 2013

AAMI TIR45 on the use of agile methods becomes new FDA recognized standard

The AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software enters in the list of recognized standards by the FDA. See here on Federal Register website.

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Friday 18 January 2013

Class A, B and C. When to do detailed design of software medical devices?

In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.

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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 30 March 2012

Inflation of software medical devices - part 2

Today I’m going to talk about the inflation to regulations in the world of software for medical devices. In my previous post, I had a look at the inflation of standards for medical devices. As the medical devices industry is heavily controlled by regulations, they deserve a dedicated post.

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Wednesday 22 February 2012

The essential list of guidances for software medical devices

Too many documents in too many places, that’s what I felt the first time I looked for guidances and other similar stuff about software medical devices.
Where do I find relevant documents?
Which one do I begin with?
My answer:
I created a page where I gather my own list of guidances. It’s a selection of guidances and recommendations for CE mark.

Click here to see the list.

Hope you enjoy it :-)

Monday 6 February 2012

MEDDEV 2.1/6 Guidelines on classification of standalone software released!

New! MEDDEV 2.1/6 Guidelines on classification of standalone software released!
HIS, CIS, PDMS, RIS, PACS, LIMS … Which ones are medical devices, which ones are not?
To answer this question, the European Commission issued a new Guidelines document: MEDDEV 2.1/6, about the qualification and classification of standalone software as Medical Devices or In Vitro Diagnosis Devices.
Download here
After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months about standalone software.

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Monday 28 November 2011

New Device Classification Guidance published by GHTF: consequences for medical imaging software

The GHTF (Global Harmonization Task Force) issued a draft of a new guidance on medical device classification They recommend to implement four classes for medical devices based on intended use: from class A (lowest risk) to class D (highest risk). And they give a set of rules on how to choose the classification of the devices.

Comparison with regulations

Wait, I've already seen this elsewhere. Classification of devices in Europe (CE mark) and in Canada have systems very similar to what GHTF recommends. This is a good thing to have an ongoing harmonization process. National regulations copy what GHTF recommends and GHTF copies what national regulations require. This is a virtuous circle. Maybe one day the FDA will implement this classification system.

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