Medical compliance needs to be considered when developing healthcare mobile applications that will be in the public domain.
The MHRA, EU and the US all have specific guidelines which need to be adhered to when developing medical device apps.
Choosing the right medical device app developer
Developing mobile applications that function as medical devices is complex. Choosing the right partner is more than just about assessing their technical capability.
Medical device app developers also need to understand the regulatory and security requirements. Working with an inexperienced company can prove extremely costly. This could be in the form of a fine due to a regulatory violation but it could also result in app store rejection, meaning that you won’t be able to distribute your app for download.
Our significant experience in developing health and medical apps has provided us with a deep understanding of the complexities of medical device compliance in mobile application development as well as the intricacies of balancing usability with security and privacy.
How can we help?
The first stage is to assess whether your app product meets the definition of a medical device. If it does then it will need to conform with the medical device regulations for each territory it will be marketed in.
We will assess the need for CE marking your app and we will support you by following the correct software development processes and standards and produce the necessary paperwork for your Technical File. Meeting the requirements of the appropriate regulatory requirements and applying CE marking has to take place before the medical device app can be placed on the market.
We have considerable experience in developing medical device apps & CE marking:
- Rosemont Pharmaceuticals liquid medicines dosage calculator app. This was the first CE Marked pharmaceutical app developed in 2014 and is registered as a Class 1 medical device
- King’s College London / Guy’s & St Thomas’ QUiPP medical calculator app
- Dosing calculator pharma app designed for a pharmaceutical company for use by HCPs that need to calculate the required dose for correct blood coagulation.
- Fertility app OvuSense™ – a unique, real-time ovulation cycle monitoring system.
We also have experience of connecting apps to medical devices using Bluetooth and NFC technology. We have experience of working to various quality standards (ISO 14971, ISO 13485, IEC 62304) including developing the appropriate regulatory documents and technical files relating to the development of software as a medical device (SaMD). 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.
Get in touch to discuss a CE marking and medical device app development project.