Professional training programmes covering EU regulatory frameworks, international standards, and practical implementation — designed for healthcare compliance professionals across the European Union.
Comprehensive introduction to the EU regulatory landscape for healthcare: GDPR, EHDS, NIS2, MDR/IVDR, AI Act, and cross-border healthcare directives. For compliance professionals new to the EU framework. 24 hours.
Deep dive into EHDS Regulation (EU 2025/327): primary and secondary use, EHR certification, data quality requirements, interoperability standards, and implementation roadmap. For CIOs, DPOs, and compliance managers. 16 hours.
NIS2 obligations for healthcare management bodies: governance requirements, risk management, incident response, supply chain security, and personal liability. For board members and C-suite executives. 8 hours.
Navigating multiple accreditation systems across EU Member States: JCI 8th edition, EN 15224, ISO 15189, and national systems. Standards mapping and harmonisation strategies. 16 hours.
Medical Device and In Vitro Diagnostic Regulation compliance: classification, conformity assessment, clinical evaluation, post-market surveillance, and EUDAMED vigilance reporting. 16 hours.
The EU Artificial Intelligence Act applied to healthcare: risk classification of AI medical devices, conformity assessment, clinical validation requirements, and transparency obligations. 8 hours.
Clinical compliance across the EU integrates with a specialised ecosystem covering every dimension of healthcare regulation — from data protection and cybersecurity to sector-wide compliance and dedicated officer services.
Central hub for comprehensive healthcare regulatory compliance
Visit healthcarecompliance.pt →Data protection in clinical research and healthcare practice
Visit clinicaldataprotection.pt →Specialised cybersecurity for hospitals and healthcare organisations
Visit healthcybersecurity.pt →Clinical compliance platform for Portuguese healthcare organisations
Visit clinicalcompliance.pt →Interested in EU compliance training for your team? Contact us for a customised programme tailored to your organisation's needs.