MedTech Academy

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Startdato	Emne	Type	Arbejdsområde
07.09.2026 31.08.2026	Person Responsible for Regulatory compliance according to MDR and IVDR – 7 September 2026 This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept...	Kursus	Regulatorisk Læs mere
21.09.2026 16.09.2026	Technical Documentation for Medical Devices - 21 September 2026 You will understand the technical documentation requirements as specified in the MDR and relevant guidance documentation and...	Kursus	Regulatorisk Læs mere
25.09.2026 20.09.2026	Introduktion til UDI (Unique Device Identification) - Identifikation og mærkning af medicinsk udstyr - 25. september 2026 Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...	Kursus	Innovation Læs mere
28.09.2026 24.09.2026	Digital markedsføring af medicinsk udstyr - 28. september 2026 Du bliver i stand til at mestre reglerne inden for digital markedsføring af medicinsk udstyr. Du lærer at identificere...	Kursus	Afsætning Læs mere
29.09.2026 22.09.2026	US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices - 29-30 September 2026 The course focuses on the newly published Quality Management System Regulation (QMSR) that replaces the Quality System...	Kursus	Regulatorisk Læs mere
01.10.2026 24.09.2026	IEC 60601 - How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems - 1-2 October 2026 How to apply safety and risk management to medical electrical equipment and systems.	Kursus	Regulatorisk Læs mere
01.10.2026 28.09.2026	New update on China NMPA Regulation and Registration for Medical Devices with Case Studies - 1-2 October 2026 You will get a deep understanding of the up-to-date China NMPA regulatory policies.	Kursus	Regulatorisk Læs mere
05.10.2026 29.09.2026	IRCA Certified ISO 13485 QMS Lead Auditor Training for Medical Devices - 5-9 October 2026 This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an...	Kursus	Regulatorisk Læs mere
05.10.2026 28.09.2026	Training of internal auditors in relation to country specific requirements within the MDSAP program - 5 October 2026 The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...	Kursus	Regulatorisk Læs mere
07.10.2026 01.10.2026	AI-drevet forretningsudvikling - 7-8 oktober Kurset kombinerer forståelse for teknologien med konkrete metoder, så deltagerne ikke blot lærer, hvad generativ AI er, men...	Kursus	Læs mere
22.10.2026 15.10.2026	Process Validation - 22-23 October 2026 Every company producing medical devices needs to understand how to practically accomplish process validation.	Kursus	Regulatorisk Læs mere
26.10.2026 19.10.2026	MDR Auditing - Training of Internal Auditors in Relation to MDR - 26 October 2026 Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS...	Kursus	Regulatorisk Læs mere
28.10.2026 26.10.2026	Introduktion til medicobranchen - 28. oktober 2026 Kurset henvender sig bredt til medarbejdere i medicoindustrien, der har brug for indsigt i branchen og en forståelse for de...	Kursus	Regulatorisk Læs mere
02.11.2026 30.10.2026	Project Management for Product Development of Medical Devices - 2-4 November 2026 The course is focused on how to manage the development process for new medical devices and maintaining them in an...	Kursus	Innovation Læs mere
04.11.2026 30.10.2026	Planning an Effective Post Market Surveillance Program for Medical Devices - 4 November 2026 During the last years the request and requirements on PMS has increased and more is in the ISO 13485:2016 and the new...	Kursus	Regulatorisk Læs mere
05.11.2026 25.10.2026	AI in Medical Device Quality Systems - 5-6 November 2026 Participants will learn to identify valuable AI use cases, establish governance frameworks, assess risks, and integrate AI...	Kursus	Læs mere
09.11.2026 02.11.2026	ISO 13485 and Quality Management for Medical Devices / Internal Auditing - 9-11 November 2026 Get an introduction to the ISO 13485:2016 standard and the legislation regarding medical devices. In addition, an insight...	Kursus	Regulatorisk Læs mere
12.11.2026 07.11.2026	Sundhedssystemets opbygning & Market Access - 12.-13. november 2026 Du lærer, hvordan man får medicinsk udstyr ud på det danske marked og ind i det danske sundhedsvæsen.	Kursus	Afsætning Læs mere
12.11.2026 05.11.2026	Generating Clinical Evidence for Medical Devices using 14155 and ISO 18969 - 12-13 November 2026 Build a stronger clinical evidence strategy across the entire medical device lifecycle. This two-day course shows how...	Kursus	Regulatorisk Læs mere
16.11.2026 09.11.2026	Design Control - 16-17 November 2026 This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design...	Kursus	Innovation Læs mere
23.11.2026 16.11.2026	Medical Device Usability - 23-24 November 2026 The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...	Kursus	Regulatorisk Læs mere
26.11.2026 23.11.2026	Risk Management for Medical Devices according to ISO14971 This two-day course provides hands-on methods for managing the risk of harm to patients, users and others, in development...	Kursus	Innovation Læs mere
30.11.2026 23.11.2026	Industrial Sterilization of Medical Devices - An Introduction to the Practical Approach of Sterilization - 30 November 2026 The key purpose of the course is to make the participants able to make a qualified initial choice of the most suitable...	Kursus	Regulatorisk Læs mere
04.12.2026 01.12.2026	Introduktion til udbudsloven - 4. december 2026 Et kursus for dig der har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...	Kursus	Regulatorisk Læs mere
07.12.2026 07.12.2026	Practical Leadership in MedTech – From Specialist to Impactful Leader - 7-8 December 2026 This intensive two-day course provides practical tools and leadership frameworks tailored specifically to Medtech realities...	Kursus	Læs mere
09.12.2026 07.12.2026	Rules on Advertising, Affiliation, and Financial Benefits - 9 December 2026 The course is based on the Danish advertising rules for medical devices and focuses on the regulations concerning financial...	Kursus	Afsætning Læs mere
10.12.2026 08.12.2026	FDA Regulation of Medical Devices: Recent FDA Guidance Documents - 10-11 December 2026 It is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in...	Kursus	Regulatorisk Læs mere
14.12.2026 07.12.2026	Reimbursement as a Driver for Commercial and Clinical Strategies - 14 december 2026 You will be able to direct commercial and clinical strategies towards the development of a market access programme that will...	Kursus	Afsætning Læs mere
15.12.2026 08.12.2026	Threat Modelling, Security Architecture and Controls for Medical Devices: Attacking and Defending - 15-16 December 2026 You will gain experience with articulating threats in a threat model, how to apply tools like MITRE ATT...	Kursus	Regulatorisk Læs mere
17.12.2026 28.11.2026	IEC 62304: Software Lifecycle - 17-18 December 2026 This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of a software as...	Kursus	Regulatorisk Læs mere
21.12.2026 15.12.2026	Corrective & Preventive Actions (CAPA) - 21 December 2026 This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...	Kursus	Regulatorisk Læs mere
18.01.2027 11.01.2027	Introduction to IVDR for CE Marking - 18-19 January 2027 This course will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the...	Kursus	Regulatorisk Læs mere
22.01.2027 21.01.2027	Introduktion til UDI (Unique Device Identification) - Identifikation og mærkning af medicinsk udstyr - 22. januar 2027 Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...	Kursus	Innovation Læs mere
28.01.2027 21.01.2027	Introduction to MDR (2017/745) - 28-29 January 2027 The course will thoroughly cover and explain the key areas that manufacturers, importers, and distributors need to...	Kursus	Regulatorisk Læs mere
01.02.2027 24.01.2027	IEC 60601 - How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems - 1-2 February 2027 How to apply safety and risk management to medical electrical equipment and systems.	Kursus	Regulatorisk Læs mere
04.02.2027 01.02.2027	Gap between ISO 9001 and ISO 13485 This one-day course is designed for professionals who are already familiar with ISO 9001 and want to understand the...	Kursus	Regulatorisk Læs mere
22.02.2027 15.02.2027	Person Responsible for Regulatory compliance according to MDR and IVDR – 22 Februar 2027 This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept...	Kursus	Regulatorisk Læs mere
25.02.2027 24.02.2027	Combination Products – Regulatory & Quality Introduction - 25-26 February 2027 The course is focused on the regulatory challenges for combination products and will give a detailed description of the...	Kursus	Regulatorisk Læs mere
04.03.2027 28.02.2027	MDR Auditing - Training of Internal Auditors in Relation to MDR - 4 March 2027 Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS...	Kursus	Regulatorisk Læs mere
15.03.2027 13.03.2027	Training of internal auditors in relation to country specific requirements within the MDSAP program - 15 March 2027 The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...	Kursus	Regulatorisk Læs mere
19.03.2027 15.03.2027	Introduction to Chemical Compliance for Medical Devices - 19 March 2027 The objective is to give participants an understanding of their obligations regarding justification of chemical safety of...	Kursus	Regulatorisk Læs mere
02.04.2027 30.03.2027	Introduction to Polymer Materials in Medical Devices - from a Biocompatibility Risk Perspective - 2 April 2027 The course provides a fundamental understanding of polymer materials, with an emphasis on commonly used plastics in medical...	Kursus	Læs mere
12.04.2027 07.04.2027	Project Management for Product Development of Medical Devices - 12-14 April 2027 The course is focused on how to manage the development process for new medical devices and maintaining them in an...	Kursus	Innovation Læs mere
26.04.2027 16.04.2027	AI in Medical Device Quality Systems - 26-27 April 2027 Participants will learn to identify valuable AI use cases, establish governance frameworks, assess risks, and integrate AI...	Kursus	Læs mere
03.05.2027 27.04.2027	Process Validation - 3-4 May 2027 Every company producing medical devices needs to understand how to practically accomplish process validation.	Kursus	Regulatorisk Læs mere
10.05.2027 06.05.2027	ISO 13485 and Quality Management for Medical Devices / Internal Auditing - 10-12 May 2026 Get an introduction to the ISO 13485:2016 standard and the legislation regarding medical devices. In addition, an insight...	Kursus	Regulatorisk Læs mere
13.05.2027 06.05.2027	Generating Clinical Evidence for Medical Devices using 14155 and ISO 18969 - 13-14 May 2027 Build a stronger clinical evidence strategy across the entire medical device lifecycle. This two-day course shows how...	Kursus	Regulatorisk Læs mere
20.05.2027 17.05.2027	Medical Device Usability - 20-21 May 2027 The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...	Kursus	Regulatorisk Læs mere
24.05.2027 21.05.2027	Design Control - 24-25 May 2027 This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design...	Kursus	Innovation Læs mere
09.06.2027 02.06.2027	Medicovirksomheders behandling af personoplysninger – juridiske og praktiske udfordringer - 9. juni 2027 Du får et overblik over relevant databeskyttelsesret, herunder GDPR og særlovgivning, og hvordan reglerne anvendes i praksis...	Kursus	Regulatorisk Læs mere
10.06.2027 07.06.2027	Introduktion til udbudsloven - 10. juni 2027 Et kursus for dig der har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...	Kursus	Regulatorisk Læs mere
11.06.2027 05.06.2027	Corrective & Preventive Actions (CAPA) - 11 June 2027 This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...	Kursus	Regulatorisk Læs mere
14.06.2027 13.06.2027	MDSAP Fundamentals and Readiness Training - 14-15 June 2027 You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...	Kursus	Regulatorisk Læs mere
06.09.2027 28.08.2027	Anatomi, fysiologi & sygdomslære - 6.-7. september 2027 Du får overordnet viden om og forståelse for den menneskelige organismes opbygning og funktion hos raske og syge mennesker.	Kursus	Innovation Læs mere
22.09.2027 15.09.2027	US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices - 22-23 September 2027 The course focuses on the newly published Quality Management System Regulation (QMSR) that replaces the Quality System...	Kursus	Regulatorisk Læs mere
24.09.2027 19.09.2027	Introduktion til UDI (Unique Device Identification) - Identifikation og mærkning af medicinsk udstyr - 24. september 2027 Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...	Kursus	Innovation Læs mere
27.09.2027 20.09.2027	Person Responsible for Regulatory compliance according to MDR and IVDR – 27 September 2027 This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept...	Kursus	Regulatorisk Læs mere
28.09.2027 23.09.2027	Technical Documentation for Medical Devices - 28 September 2026 You will understand the technical documentation requirements as specified in the MDR and relevant guidance documentation and...	Kursus	Regulatorisk Læs mere
29.09.2027 22.09.2027	IEC 60601 - How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems - 29-30 September 2027 How to apply safety and risk management to medical electrical equipment and systems.	Kursus	Regulatorisk Læs mere
14.10.2027 07.10.2027	Training of internal auditors in relation to country specific requirements within the MDSAP program - 14 October 2027 The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...	Kursus	Regulatorisk Læs mere
25.10.2027 20.10.2027	MDR Auditing - Training of Internal Auditors in Relation to MDR - 25 October 2027 Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS...	Kursus	Regulatorisk Læs mere
28.10.2027 17.10.2027	AI in Medical Device Quality Systems - 28-29 October 2027 Participants will learn to identify valuable AI use cases, establish governance frameworks, assess risks, and integrate AI...	Kursus	Læs mere
01.11.2027 24.10.2027	Process Validation - 1-2 November 2027 Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Regulatorisk Læs mere
03.11.2027 27.10.2027	ISO 13485 and Quality Management for Medical Devices / Internal Auditing - 3-5 November 2027 Get an introduction to the ISO 13485:2016 standard and the legislation regarding medical devices. In addition, an insight...	Kursus	Regulatorisk Læs mere
08.11.2027 01.11.2027	Design Control - 8-9 November 2026 This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design...	Kursus	Innovation Læs mere
11.11.2027 04.11.2027	Generating Clinical Evidence for Medical Devices using 14155 and ISO 18969 - 11-12 November 2027 Build a stronger clinical evidence strategy across the entire medical device lifecycle. This two-day course shows how...	Kursus	Regulatorisk Læs mere
15.11.2027 12.11.2027	Risk Management for Medical Devices according to ISO14971 - 15.-16. november 2027 This two-day course provides hands-on methods for managing the risk of harm to patients, users and others, in development...	Kursus	Innovation Læs mere
22.11.2027 19.11.2027	Medical Device Usability - 22-23 November 2027 The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...	Kursus	Regulatorisk Læs mere
24.11.2027 17.11.2027	Project Management for Product Development of Medical Devices - 24-26 November 2027 The course is focused on how to manage the development process for new medical devices and maintaining them in an...	Kursus	Innovation Læs mere
02.12.2027 25.11.2027	MDSAP Fundamentals and Readiness Training - 2-3 December 2027 You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...	Kursus	Regulatorisk Læs mere
06.12.2027 30.11.2027	Industrial Sterilization of Medical Devices - An Introduction to the Practical Approach of Sterilization - 6 December 2027 The key purpose of the course is to make the participants able to make a qualified initial choice of the most suitable...	Kursus	Regulatorisk Læs mere
07.12.2027 01.12.2027	Reimbursement as a Driver for Commercial and Clinical Strategies - 7 December 2027 You will be able to direct commercial and clinical strategies towards the development of a market access programme that will...	Kursus	Afsætning Læs mere
10.12.2027 07.12.2027	Introduktion til udbudsloven - 10. december 2027 Et kursus for dig der har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...	Kursus	Regulatorisk Læs mere
13.12.2027 07.12.2027	Corrective & Preventive Actions (CAPA) - 13 December 2027 This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...	Kursus	Regulatorisk Læs mere

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MedTech Academy

MedTech Academy