CE Marking & Compliance
Medical compliance is one of the key components of developing an effective healthcare digital strategy
The MHRA/EU and the US now have a set of specific guidelines which need to be adhered to when developing stand-alone software and apps that act as a medical device.
We have considerable experience of CE Marking apps and we developed one of the first CE Marked pharmaceutical apps for a client back in 2014. We also have experience of connecting apps to Class 1 and 2 medical devices using Bluetooth and NFC technology. We have experience of working to various ISO standards (ISO 14971, ISO 13485, ISO 62304) including developing the appropriate regulatory documents and technical files for software as a medical device (SaMD) development projects. Our documentation for CE marking apps also contains the required information to conform with British Standard EN 62304:2006 Medical Device Software, Software Life-Cycle Processes.