SaMD & Digital Health
The future of healthcare is digital. We help healthtech innovators design, develop, and certify Software as a Medical Device (SaMD) and connected digital health platforms that improve patient outcomes and clinical workflows — built to meet both technical and regulatory excellence.
01.
End-to-End SaMD Development
Transform your medical idea into a market-ready digital product — from concept and prototyping to validation, certification, and launch, following the highest quality and safety standards.
02.
Clinical Data Integration
Enable secure and seamless interoperability with EHR, FHIR, and hospital systems, ensuring your platform fits smoothly into real clinical workflows and drives actionable insights.
03.
Regulatory-Ready Design
Build your SaMD right the first time with compliance to ISO 13485, IEC 62304, and HIPAA frameworks, reducing approval delays and simplifying audits down the road.
04.
Cloud & AI Enablement
Leverage compliant cloud infrastructure and intelligent AI modules to power remote monitoring, patient analytics, and smarter decision support — all built for reliability and scale.
05.
Post-Market Support & Validation
Maintain continuous compliance and clinical confidence with lifecycle support, documentation updates, and validation services for every new software release.
Who We Work With:
Clinician Founders
HealthTech Startups
Academic Institutes
Medical Device Companies
Frequently asked questions
We guide you through the entire SaMD journey. from ideation and clinical validation to regulatory submission and cloud deployment. Our team combines engineering, quality management, and compliance expertise to build products ready for global markets.
If your app processes health data for diagnosis, analysis, or clinical decision support, then yes - it may qualify as SaMD. MetaCXO helps you determine classification, prepare technical documentation, and achieve certifications such as ISO 13485 or CDSCO registration.
Once your product hits the market, MetaCXO continues to support you through post-market surveillance, updates, and change management - ensuring ongoing compliance, security, and quality maintenance.