Software to measure your muscle activity

Muscle activity monitoring tools are increasingly being adopted in various medical settings, and certification is critical for any new product to gain market trust. Myoact wanted to ensure that their software would meet the necessary regulatory standards, especially as other products in the market were already certified.

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.

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. Certification would provide the stamp of regulatory approval needed to differentiate them from uncertified competitors and open doors to wider adoption.

With Formly’s eQMS and AI-powered documentation tools, Myoact was able to streamline their regulatory efforts. Our platform allowed them to manage quality documentation, maintain regulatory compliance, and stay organized as they pursued their Class I medical device certification.

"The market was already filled with certified products," said the Myoact team. "We knew that to be taken seriously, we needed our certification. Formly’s tools made the process clear and efficient, allowing us to move forward confidently."

Achieving certification not only validated Myoact's product but also helped build credibility with potential partners and customers. The certification process, which could have been a significant obstacle, was handled swiftly through Formly, allowing Myoact to keep pace with competitors who had already completed their certifications.

Myoact is now positioned for future growth, with plans to pursue Class IIA certification as they expand their analysis tools. 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.

By integrating Formly.ai, Myoact validated their product with Class I certification, ensuring they could compete in the medical device space. Certification helped them gain credibility, access selective insurance reimbursement, and prepare for future growth.

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