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 7. September 2026 Person Responsible for Regulatory Compliance according to MDR and IVDR 21. September 2026 Technical Documentation for Medical Devices 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 US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices 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 5. October 2026 Training of internal auditors in relation to country specific requirements within the MDSAP program 22. October 2026 Process Validation 26. October 2026 MDR Auditing - Training of Internal Auditors in Relation to MDR 28. October 2026 Introduktion til medicobranchen 2. November 2026 Project Management for Product Development of Medical Devices 4. November 2026 Planning an Effective Post Market Surveillance Program for Medical Devices 5. November 2026 AI in Medical Device Quality Systems 9. November 2026 ISO 13485 and Quality Management for Medical Devices / Internal Auditing 12. November 2026 Clinical Evaluation and Investigation for Medical Devices: ISO 14155 and ISO 18969 12. November 2026 Sundhedssystemets opbygning & Market Access 16. November 2026 Design Control 23. November 2026 Medical Device Usability 26. November 2026 Risk Management for Medical Devices according to ISO14971 30. November 2026 Industrial Sterilization of Medical Devices - An Introduction to the Practical Approach of Sterilization 4. December 2026 Introduktion til udbudsloven 7. December 2026 Practical Leadership in Medtech – From Specialist to Impactful Leader 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 17. December 2026 IEC 62304: Software Lifecycle 21. December 2026 Corrective & Preventive Actions (CAPA) 18. January 2027 Introduction to the IVDR for CE Marking 28. January 2027 Introduction to MDR (2017/745) 4. February 2027 Gap between ISO 9001 and ISO 13485 25. February 2027 Combination Products - Regulatory & Quality Introduction 19. March 2027 Introduction to Chemical Compliance for Medical Devices 2. April 2027 Introduction to Polymer Materials in Medical Devices - from a Biocompatibility Risk Perspective 9. June 2027 Medicovirksomheders behandling af personoplysninger – juridiske og praktiske udfordringer 14. June 2027 MDSAP Fundamentals and Readiness Training 6. September 2027 Anatomi, fysiologi & sygdomslære Kontakt Berit MunkeboUdviklingschef / Business Development Manager 60 47 66 49 bm@medicoindustrien.dk
