Stay Ahead of AI Act & MDR Compliance for Healthcare Software
Effectum Medical helps you ensure conformity for AI/ML-based medical devices—covering MDR, IVDR, and the upcoming EU AI Act.
Stay Ahead of AI Act & MDR Compliance for Healthcare Software
Effectum Medical helps you ensure conformity for AI/ML-based medical devices—covering MDR, IVDR, and the upcoming EU AI Act.
AI / ML Expert
AI in healthcare promises huge benefits - but it introduces new regulatory obligations. We guide startups and software teams through the process of certifying their AI/ML medical devices under MDR and the EU AI Act.
Key Services
- Gap analyses for AI Act & MDR/IVDR
- Regulatory strategy: dual vs. single regulation paths
- CE certification support for AI-driven software
- AI-specific technical documentation templates
- Lifecycle monitoring frameworks for post-market compliance
- Optional review of data governance, transparency, and bias documentation
AI / ML Expert
- Specialized certification pathways and compliance services for AI-based medical devices.
Key Benefits
- Specialized guidance: From experts in software, devices, and AI regulation
- Time-efficient: Accelerate readiness through proven templates and workflows
- Risk-managed: Identify issues before they affect submissions
- Lifecycle-aligned: Support extends to post-market monitoring and AI behavior audits
- Leading practice-aligned: Offering on par with RQM+, Veranex, and Celegence AI readiness frameworks
