Challenge: A startup developed a mobile application for therapy adherence that qualified as a Class IIa medical device under MDR but lacked the internal regulatory expertise to navigate software requirements.

Solution: MDx delivered:

• • Complete IEC 62304 implementation and documentation

• • Cybersecurity risk assessment and documentation

• • Usability engineering process aligned with IEC 62366

• • Clinical evaluation strategy based on real-world evidence collection

Result: CE marking achieved in 11 months, enabling the client to launch in the European market ahead of competitors.