- HealthcareCompliance
Beyond Clinical Excellence: Mastering Agentic Healthcare Compliance
Orchestrate your market access across Switzerland, the EU, and the UK with the speed of AI and the precision of Swiss engineering.
Who This Solution Is For
This solution is designed for healthcare organisations operating in high-trust, highly regulated environments, including:
HealthTech & Digital Health companies
Processing patient or clinical data
MedTech & medical device manufacturers
Integrating software, cloud and connected systems
Life sciences & research organisations
Subject to human research and clinical trial regulations
International healthcare companies
Entering Swiss and EU markets from the US or other regions. Entering the US market from EU or CH
If your product touches health data, research data or regulated healthcare infrastructure, this solution is built for you.
Why Healthcare Compliance is No Longer a Manual Task
In 2026, the complexity for HealthTech, MedTech, and Life Sciences firms has reached a critical peak. Navigating the divergence between the EU AI Act, Swiss MedDO, and the UK’s post-Brexit medical regulations requires more than a spreadsheet—it requires a regulatory brain.
Current pain points for European healthcare innovators:
The result is delayed audits, blocked sales cycles and slower market entry.
The 360vue Engine: Your Agentic Regulatory Workforce
We have evolved 360vue from a passive dashboard into an active Agentic AI workforce. It doesn’t just track your compliance; it executes it across jurisdictions.
360vue’s agents pull data directly from your engineering pipeline to draft and update the Technical Files required for Swiss and EU Notified Body reviews.
Our agents autonomously manage your registration data across Swissdamed, EUDAMED, and the UK MHRA registry.
We combine Swiss-based legal experts with AI agents that monitor 24/7 for safety signals, automating mandatory reporting to international authorities.
Sovereignty as a Standard
For healthcare firms handling sensitive clinical data, 360vue provides a Swiss-Sovereign cloud environment. We fulfill the highest Swiss FADP and GDPR requirements, ensuring patient data is protected by the world’s gold standard in privacy.
Pan-European & Global Framework Coverage
Accelerate your international scaling with unified governance across every major healthcare market:
FRAMEWORK
Region
Impact for 2026
Swiss MedDO / IvDO
Switzerland
Mandatory for the Swiss market; requires a CH-REP for foreign firms.
EU MDR / IVDR
European Union
The essential passport for European market access.
UK MHRA / UKCA
United Kingdom
Navigating the unique post-Brexit requirements for the UK health system.
EU AI Act
EU / Global
High-risk classification for most AI-enabled medical software, requiring strict "Human-in-the-loop" controls.
HIPAA / HITRUST
USA / Global
The necessary standard for Swiss and EU firms expanding into the US market.
2026 Healthcare Compliance Guide: EU AI Act, MDR, Swiss MedDO & FDA Readiness for HealthTech and MedTech
Practical 2026 compliance roadmap for HealthTech and MedTech covering EU AI Act, MDR, Swiss MedDO, HRA, GDPR and FDA QMSR market readiness.
Sneak peak on the Healthcare Compliance Guide
Sneak peak on the Healthcare Data Transfer Checklist
2026 Healthcare Data Transfer Checklist: Swiss FADP, GDPR & UK GDPR Cross-Border Compliance Guide
Checklist for secure cross-border healthcare data transfers under Swiss FADP, GDPR, UK GDPR, HRA and EU AI Act in 2026 regulated markets.
2026 International Healthcare Compliance Blueprint: EU MDR, AI Act, Swiss FADP & UK GDPR Market Entry Guide
Practical 2026 healthcare compliance roadmap covering EU MDR, AI Act, Swiss FADP, HRA and UK GDPR for HealthTech, MedTech and life sciences expansion.
Sneak peak on the Healthcare Compliance Blueprint
Healthcare Compliance FAQs – Regulations, Frameworks and Applicability
Clear answers to common healthcare compliance questions, including which regulations and frameworks apply to HealthTech, MedTech and life sciences companies operating in Switzerland, the EU and the US.
Healthcare Compliance Frequently Asked Questions
360vue uses unified data mapping to ensure that a single privacy control satisfies all three jurisdictions simultaneously, reducing redundant legal work by up to 60%.
Yes. We support governance aligned with the Swiss Human Research Act (HRA) and the EU Clinical Trials Regulation (CTR), centralizing patient consent and data impact assessments in one workspace.
Absolutely. We provide the platform and the legal expertise to act as your CH-REP, ensuring your technical documentation is available to Swissmedic within the required 7-day window.
Yes. We support healthcare organisations operating across Switzerland, the EU and the US, including companies subject to Swiss FADP, GDPR, HIPAA and other healthcare-specific regulations. Each compliance program is tailored to your product, data flows and target markets.
