Software design for medical devices

I just returned from an interesting conference in Munich about software design for medical devices. I had the privilege to present on legal issues and some regulatory issues related to software and EU medical devices law. The crowd was an interesting mix of experts that all carried different parts of the puzzle: some in-house lawyers, many software developers, some people concerned with QA/RA activities. Unfortunately I could not stay for another day to have more discussions with the people present.

A lot can obviously be said about the subject but I think in particular my concluding observations on the influence of the current eHealth activities and the upcoming EU medical devices recast on requirements and on companies’ processes will be interesting for readers of this blog to take a look at. Presently, for example, the eHealth discussion and the medical devices legal/regulatory discussion seem to be distinct subjects while current and near-future developments while there is a very clear convergence between eHealth services and software as standalone medical device or on a medical device functioning in a eHealth setting, e.g. a wearable heart monitor that connects to a managed care facility’s server via a wifi network and the internet. Somehow this convergence is overlooked regularly, not in the least by the medical profession.

Other presentations that I found particularly interesting were the Abbott presentation on usability engineering for software, the Philips presentation on practical application of the EU harmonised software lifecycle standard EN 62304 and the Swedish Medtech presentation on the Swedish push for better regulation of the use of software in a clinical setting that led to the by now famous ‘Swedish document‘ that is currently used as basis for the EU MEDDEV medical devices guidance document on software currently in the works (which, we heard, may not even make it out this year and may perhaps be delayed until 2012).

Navigate through our knowledgebase

Related articles


New sort of applicable economic operators regulation: the Market Surveillance Regulation

Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in…

Read more


Transparency vs. Confidentiality: EFSA’s new role as from March 2021

Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the […]


€ 500 per data subject – a quantification of why GDPR matters

Clients often ask me why they should invest in General Data Protection Regulation (GDPR) compliance so much. For medical devices and medicines regulatory compliance, they get it to an extent. Non-compliant devices…

Read more