Explore. Simplify. Innovate.
Synchronising Quality, Innovation, and Compliance for a Healthier Tomorrow
Discover practical, future-ready frameworks for Medical Devices, Health Software, and AI in Healthcare – all in one place.
✓ medical device
✓ health software
✓ ai enbaled medical device
Frameworks That Simplify Complexities
We deliver comprehensive, actionable frameworks designed to align with international standards and evolving regulatory landscapes. Each framework is patient-centric, risk-based, and built on global best practices.
Whether you are a startup navigating regulatory hurdles or an established player streamlining your Quality Management System (QMS), Medixshift helps you shift the way you approach compliance and quality – strategically and seamlessly.
About MediXShift
At Medixshift, we believe the future of healthcare lies at the intersection of Quality, Innovation, and Patient-Centric Design. Our mission is to simplify the complexities of regulatory compliance and quality management, enabling organisations to accelerate innovation without compromising safety, reliability, or compliance.
Framework for Medical Devices
End-to-end roadmap from concept to post-market surveillance
Compliant with ISO 13485, MDR, FDA QSR, IVDR, and IEC 62366
Emphasises Quality by Design (QbD) and Human Factors Engineering
Framework for Health Software
Covering IEC 62304, IEC 82304, and cybersecurity integration (ISO 27001)
Simplifies software lifecycle requirements with real-world implementation guidance
Ensures usability, interoperability, and data security compliance
Framework for AI in Healthcare
Built on Good Machine Learning Practices (GMLP) and AI Risk Management (ISO 42001)
Addresses ethical AI principles, transparency, and regulatory readiness
Supports AI validation, bias monitoring, and continuous improvement strategies