NeuroMind 2.5 – what is happening?

I have started to work on NeuroMind 2.5, which will replace the current (2.2) version. Why 2.5? Because it will be an intermediate step in something very important: CE marking. US people may be familiar with the FDA guideline on mobile medical applications, and in Europe we have the CE mark. According to the official website it means that “the product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements”. Also the Dutch healthcare inspectorate started to focus on “software as a medical device”.

To be compliant with the European MEDDEV directives and the Dutch regulations (FDA guideline is “non binding”, so currently less urgent) I need to make some fundamental changes to NeuroMind. The most important issue that needs to be addressed is how to minimize the chance that an error in the software actually can damage patients. And for that question, it is important that if an error is present (e.g. in my programming code of a decision support item) I can change it quickly. Evaluating the options I chose to switch the location where the content is stored from the device to the web. This means that NeuroMind 2.5 will only work when you have Internet connection, but in 2014 this should not be a big issue for most of you (WiFi, 3G, 4G). This gives all of us a few advantages:

• content updates can be implemented much easier and quicker without the need to update the app
• the content that you use is always the latest version
• errors can be corrected much faster than previously possible

As NeuroMind will be marked as a Class I device in CE terminology I am allowed to do the  certification process myself without the need to involve a so-called notified body. That is going to happen for NeuroMind 2.5: you will see the CE logo back in the app. After updating the app I can inform the healthcare inspectorate of the changes I made and have it checked. Once everything is approved I will continue to work on NeuroMind 3, for which I have a few possible surprises in mind. But that’s for later… first I need to make sure the app will be certified in a correct manner.

More to come…