With the world becoming increasingly interconnected and medical technology ever-evolving, the amount of data generated daily is growing exponentially. Medical devices are no exception, and they now produce vast amounts of high-quality patient health data and measurements.

Harnessing data for clinical decisions on patient triage, surfacing indicators, and prognosis is a top priority for medical device, IVD and pharmaceutical companies seeking to improve their products and services.

Innovative medical devices are now supporting and automating diagnosis, treatment, and preventative decisions, reducing the burden on healthcare systems, but the regulatory process for medical device software or software as a medical device (SaMD) can be complex.

We have extensive experience obtaining and maintaining regulatory approvals, having worked on a variety of medical device projects for our clients, from neonatal devices to robotic software. As regulatory specialists, we can help you ensure that your software development processes align with the requirements of IEC 62304 and ISO 13485.

If you are developing software or hardware for a medical device, or have an existing product and you need quality and regulatory support, please don’t hesitate to get in touch. QAEC Limited can help you navigate the process of bringing your digital health product or medical device to market, from concept to commercialisation.

Just let us know what you need, and if you’re unsure, we will guide you.