MedTech Academy Interne Kurser Academy News Emne Alle AI Anatomi Auditing Biocompatibility CAPA China NMPA Regulation Clinical Evaluation Combination Products Cybersecurity Design Control Digital markedsføring Electrical Safety FDA GDPR Godkendelsessystem Hygiejne og smitteveje Introduktion til medicobranchen ISO 13485 IVDR Market Access MDR MDR Auditing MDSAP PMS Process Validation Producentansvar Product Management PRRC QMSR Regulatory Reimbursement Reklameregler Risikoanalyser Software Statistik for procesvalidering Sterilization Technical Documentation Udbud UDI Usability Aktivitetstype Alle Kurser Seminarer Uddannelser Webinarer Online kurser Virksomhedsinterne kurser Dato Sprog Alle Dansk Engelsk 17. April 2026 Training of internal auditors in relation to country specific requirements within the MDSAP program 22. April 2026 Introduktion til medicobranchen 27. April 2026 Process Validation 29. April 2026 Anatomi, fysiologi & sygdomslære 29. April 2026 MedTech RA Officer - Kan købes individuelt til test 29. April 2026 Modul 1: Anatomi, fysiologi & sygdomslære - TEST enkeltkøb 29. April 2026 Modul 1: Anatomi, fysiologi & sygdomslære - TEST modulkøb 4. May 2026 ISO 13485 and Quality Management for Medical Devices / Internal Auditing 7. May 2026 Clinical Evaluation and Investigation for Medical Devices: ISO 14155 and ISO 18969 11. May 2026 Project Management for Product Development of Medical Devices 18. May 2026 Design Control 27. May 2026 Det europæiske godkendelsessystem for medicinsk udstyr i henhold til MDR og IVDR 27. May 2026 Modul 2: Det europæiske godkendelsessystem for medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik - TEST enkeltkøb 27. May 2026 Modul 2: Det europæiske godkendelsessystem for medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik - TEST modulkøb 1. June 2026 Praktisk gennemførsel af risikoanalyser ved produktudvikling 3. June 2026 MDSAP Fundamentals and Readiness Training 8. June 2026 Introduktion til udbudsloven 9. June 2026 Medico virksomheders behandling af personoplysninger – juridiske og praktiske udfordringer 10. June 2026 MDR Compliance of Medical Devices Incorporating AI/ML Algorithms 11. June 2026 Modul 3: Materialer og klinisk evaluering - TEST enkeltkøb 11. June 2026 Modul 3: Materialer og klinisk evaluering - TEST modulkøb 15. June 2026 Software as Medical Device and Quality Management 18. June 2026 IEC 62304: Software Lifecycle 19. June 2026 Eksamen 19. June 2026 Eksamen - TEST enkeltkøb 23. June 2026 Introduction to Security Risk Management for SW96 and TIR57 Compliance 7. September 2026 Person Responsible for Regulatory Compliance according to MDR and IVDR 25. September 2026 Introduktion til UDI (Unique Device Identification) - Identifikation og mærkning af medicinsk udstyr 28. September 2026 Digital markedsføring af medicinsk udstyr 29. September 2026 The New US Quality Management System Regulation (QMSR) 1. October 2026 IEC 60601 - How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems 1. October 2026 New update on China NMPA Regulation and Registration or Medical Devices 5. October 2026 IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices 4. November 2026 Planning an Effective Post Market Surveillance Program for Medical Devices 12. November 2026 Sundhedssystemets opbygning & Market Access 23. November 2026 Medical Device Usability 30. November 2026 Industrial Sterilization of Medical Devices - An Introduction to the Practical Approach of Sterilization 10. December 2026 FDA Regulation of Medical Devices: Recent FDA Guidance Documents 14. December 2026 Reimbursement as a Driver for Commercial and Clinical Strategies 15. December 2026 Threat Modelling, Security Architecture and Controls for Medical Devices: Attacking and Defending 18. January 2027 Introduction to the IVDR for CE Marking Kontakt Berit Munkebo bm@medicoindustrien.dk