adesso Blog

Many pharmaceutical and healthcare companies would like to implement and publish apps for their patients and customers. However, they fear being categorised as a medical device. In this blog post, I explain how medical device experts can ensure that such a categorisation is avoided.

The long-awaited draft guidance for Computer Software Assurance for Production and Quality System Software was published last September. Being a draft state, it’s open to comments and discussion. The non-binding final guidance will reflect FDA’s current thinking of the topic. But what can we learn from this draft guidance already?

With estimations now going past 50% of the world’s population using social media in 2021, and this number still constantly growing, it is crucial for businesses to be present on some of these networks. For pharmaceutical firms this means to take the next step closer to connect and interact differently and more directly with patients, their families and their impacted network as a whole.