FDA-Cleared Medical Device App Development

Kesem Solutions specializes in medical device app development for manufacturers worldwide. We deliver FDA 510(k) and PMA-cleared, TGA-approved applications that meet IEC 62304 and ISO 13485 compliance requirements. Our medical device app development team is based in Melbourne, Australia. We deliver FDA 510(k) and PMA-cleared, TGA-approved, and CE Mark certified mobile applications development that meet IEC 62304, ISO 13485 and HIPAA compliance requirements. With proven experience developing companion apps for Class II and Class III medical devices—including neuromodulation system , urological health platforms, and diagnostic tools—we help you get to market faster and more cost-effectively than traditional medical device development agencies.

Medical Device App Development Projects

Kesem Solutions has delivered regulatory-cleared medical device app development and mobile applications for Class II and Class III medical devices across urology, neurology, and diagnostic medicine. Our apps are used by thousands of patients and clinicians worldwide.
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Medical Device App Development Specialists

Kesem Solutions develops regulatory-compliant mobile medical device applications for medical device manufacturers, digital health startups, and healthcare technology companies worldwide. Based in Melbourne, Australia, we deliver FDA 510(k) and PMA-cleared, TGA-approved, and CE Mark certified mobile applications that meet IEC 62304, ISO 13485, and HIPAA compliance requirements.