Certification of software using wearable hardware sensors

You may think your body is perfectly balanced, but that is often not the case. Especially after you have had to recover from an injury.

One of the few ways to explore muscle activity and imbalances is using sEMG sensors. These sensors can be applied to the skin to measure the electrical activity that muscles produce when they contract. By measuring this activity during movement and comparing the same muscles on the left and right sides of your body, you can understand your body in a new way and improve it.

Myoact had developed a software application that connects to sEMG sensors, allowing users to view their muscle activity in real time. While their product offered innovative features, the team understood that in a competitive market, certification was key to being taken seriously by both practitioners and patients. To truly validate their product’s value and secure their place among other certified solutions, Myoact knew that regulatory approval under the EU’s Medical Device Regulations was essential for the long term.

This is where Formly came in. Myoact’s team approached us with a clear goal: to achieve Class I certification for their software, positioning themselves alongside other certified products in the market and would allow them to provide clinical analytical tools they would want in order for the software to be effective for the healthcare professionals who wanted to use them.

Formly’s eQMS and AI-powered documentation tool allowed Myoact to move from limited in house documentation quickly towards full certification. Myoact's team received full training on the QMS processes and the software allows them to quickly make changes to documentation for new software versions, shortening the software release cycle.

Additionally, Myoact would interface with sEMG sensors that were already on the market. Through careful regulatory strategy through discussions with the Formly team, the software was able to be certified as a standalone product without needing a dedicated hardware component to be certified alongside it.

Achieving certification not only validated Myoact's product among competitors but it also provided a path towards reimbursement through insurance, allowing more flexibility in the ways that their product can reach those that need it.

Myoact was able to meet their certification goals on time and within budget. Their experience demonstrates that small teams can successfully navigate complex processes like medical device certification when equipped with the right tools and support. Myoact now holds Class I certification for their software and continues to use Formly's eQMS to manage data and device surveillance. This ensures that any future compliance activities or updates to their product can be handled efficiently, without disrupting their software release cycles.

Myoact is now positioned for future growth, with plans to pursue Class IIA certification as they expand the capabilities and functionality of the software. They’re confident that with Formly’s continued support, they’ll be able to meet those additional regulatory requirements efficiently and stay competitive in a rapidly evolving market. Additionally, the team plans to launch in the US soon with the assistance of Formly.