About AuthSphere Solutions
Your specialized partner for navigating the complex intersection of AI innovation and medical device regulation.
Our Story
AuthSphere Solutions was founded to address a critical gap in the MedTech industry: the need for specialized expertise at the intersection of AI security and medical device regulatory compliance.
With 7 years of hands-on experience in the medical device sector, we've witnessed firsthand the challenges that companies face when trying to innovate with AI while maintaining compliance with MDR, IVDR, and now the EU AI Act.
We're not generalists trying to understand your industry. We're seasoned MedTech professionals who speak your language and understand your unique challenges. We know what Notified Bodies are looking for, what regulators expect, and how to build documentation that stands up to scrutiny.
Our Expertise
7 Years in MedTech
Deep experience across the full medical device lifecycle, from concept to post-market surveillance.
Regulatory Mastery
Expert knowledge of MDR, IVDR, ISO 13485, IEC 62304, and the emerging EU AI Act requirements.
Technical Background
Software engineering and technical product management experience in healthcare technology.
Our Approach
Practical, Not Theoretical
We deliver actionable documentation and strategies, not academic reports. Everything we create is designed to be implemented immediately.
Specialized, Not Generic
Our solutions are tailored specifically for AI/ML-enabled medical devices. We understand the unique challenges of software as a medical device (SaMD).
Partnership, Not Consulting
We work alongside your team as a trusted advisor, not a distant consultant. Your success is our success.
Ready to Work Together?
Let's discuss how we can help you navigate the complex world of AI security and medical device compliance.
Book a Free Consultation