AI Security & Compliance for Medical Devices
Navigate MDR, IVDR, and the EU AI Act with confidence. We provide the specialized policies, documentation, and strategic guidance you need to achieve and maintain compliance.
7 Years MedTech Experience
Founded by an engineer with 7 years of experience in Medical Device software development, cybersecurity, and regulatory compliance
Regulatory Expertise
MDR, IVDR, ISO 13485, EU AI Act, and cybersecurity standards
Specialized for HealthTech
Tailored solutions for AI/ML-enabled medical device companies
The Regulatory Landscape is Shifting. Are You Prepared?
Developing AI-powered SaMD is complex enough. Now, you must also prove security and compliance under MDR, IVDR, and the upcoming EU AI Act. The overlap creates critical gaps that can delay your certification and launch.
Unclear AI Governance
How do MDR's post-market surveillance and the AI Act's conformity assessments overlap? The regulatory landscape is complex and constantly evolving.
Documentation Gaps
Your technical file lacks the specific documentation for AI/ML lifecycle governance, putting your certification timeline at risk.
Security Vulnerabilities
Your team's use of GenAI (ChatGPT, Copilot) risks exposing Intellectual Property and Patient Health Information (PHI).
Audit Readiness
Notified Bodies are increasing their scrutiny of cybersecurity and data governance. Are you prepared for their questions?
Specialized Expertise, Delivered.
We bridge the gap between innovation and regulation. Get the actionable strategies and compliant documentation you need, designed specifically for AI in MedTech.
The AI Security Policy Pack for R&D
Secure Your Development Process
Stop IP leaks in R&D. We implement enforceable AI usage policies that protect patient data and proprietary algorithms from accidental exposure through tools like ChatGPT and Copilot.
Ideal for: CTOs & Engineering Leads
Outcome: Your team innovates safely, with clear guardrails.
The MDR + AI Act Gap Assessment
Identify Your Compliance Gaps
Identify compliance blind spots before your auditor does. We map your SaMD against MDR/IVDR and EU AI Act requirements, delivering a prioritized gap analysis and remediation plan.
Ideal for: Regulatory & Quality Managers
Outcome: A clear roadmap to compliance, saving months of uncertainty.
The Notified Body Readiness Package
Streamline Your Audit Preparation
A pre-structured 'Data Room' template and documentation suite. Organizes everything from risk management and traceability to AI lifecycle governance and post-market surveillance plans.
Ideal for: Founders & Quality Leads
Outcome: Walk into your audit looking mature and prepared, significantly reducing time-to-certification.
Why Choose AuthSphere Solutions?
We combine deep regulatory knowledge with practical implementation experience to deliver solutions that actually work.
Deep MedTech Expertise
7 years focused specifically on Medical Device software and regulatory frameworks. We understand your world.
Practical Solutions
We provide actionable documentation and policies, not just theoretical advice. Everything is ready to implement.
Audit-Ready Deliverables
Everything we deliver is structured to satisfy Notified Body expectations. Walk into audits with confidence.
Our Expertise
With 7 years of experience in the MedTech sector, we bring deep knowledge across the full spectrum of medical device regulations and cybersecurity standards.
Stop Guessing. Start Complying.
Book your free, no-obligation Compliance Gap Analysis call today. We'll review your current state and provide actionable recommendations.
Secure My 30-Minute Call