The increasing complexity of modern medical devices imposes the advancement of software that will provide devices with a wide variety of functionalities. Software has always been a fundamental part of many medical devices driving hardware and ensuring safety for patients and usability for the end user.
The widespread use of smart devices has seen a rise in Software Apps linking with Medical Devices and In-vitro Diagnostics. Furthermore, stand-alone apps operating as Medical Devices are also being seen more frequently. For example, the opportunity to use digital technologies to monitor a patient’s heart rate or blood pressure and electronically transmit the information to care providers has a profound impact on the healthcare landscape. In the past the main focus was on hardware, however as medical devices gradually became more easy to use and available to anyone owning a smart device, software has taken a more vital role.
Software can be either part of a medical device or it can be a medical device itself without being a part of any hardware. This opportunity allows different devices with a wide range of capabilities like operating on different platforms to connect and communicate wirelessly. These functionalities create a significant regulatory challenge in order to ensure patient safety, data accuracy and consistency. The fact that patients are now able to monitor and control their diagnosis or treatment is a great advancement but also a huge responsibility.
TCTC recognise the challenges agencies have to ensure regulations and subsequently guidance for these products is updated as the horizon evolves. However, TCTC also understands how complex and confusing this can seem to manufacturers and companies.
TCTC can support and guide you through the process at any stage in the development, to ensure you have a seamless journey to achieving compliance. TCTC are highly skilled in this area and adopt a multi-faceted approach to your needs. We can offer full consultancy advice around ISO 62304 and how to fulfil the requirements of this particular standard. Our support does not end there and can continue during the lifecycle of your device and help to prepare you for your future products and next-generation devices.