MedTech Academy

Startdato	Emne	Type	Arbejdsområde
03.09.2024 30.08.2024	Medtech Market Access Officer 2024 Uddannelsen er målrettet salgs- og marketingmedarbejdere i medicoindustrien. Formålet med uddannelsen er at gøre deltagerne...	Uddannelse	Læs mere
09.09.2024 02.09.2024	Digital markedsføring af medicinsk udstyr Du bliver i stand til at mestre reglerne inden for digital markedsføring af medicinsk udstyr. Du lærer at identificere...	Kursus	Afsætning Læs mere
10.09.2024 03.09.2024	Person Responsible for Regulatory Compliance according to MDR and IVDR This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept...	Kursus	Regulatorisk Læs mere
11.09.2024 04.09.2024	From Idea to Market Launch You will be provided a structured roadmap to process the complex commercial and regulatory elements needed to gain success...	Kursus	Afsætning Læs mere
13.09.2024 06.09.2024	Technical Documentation for Medical Devices According to the MDR BSI will learn you how to create robust technical documentation to demonstrate compliance to the MDR and better understand...	Kursus	Regulatorisk Læs mere
16.09.2024 12.09.2024	Anatomi, fysiologi & sygdomslære Du får overordnet viden om og forståelse for den menneskelige organismes opbygning og funktion hos raske og syge mennesker.	Kursus	Innovation Læs mere
16.09.2024 14.10.2024	MedTech RA Officer 2024 MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...	Uddannelse	Regulatorisk Læs mere
19.09.2024 16.09.2024	Workshop on clinical evaluations and investigations with medical devices	Seminar	Læs mere
23.09.2024 16.09.2024	Implementing Electronic Quality Management System (eQMS) in Medtech Companies Participants will receive a comprehensive understanding of eQMS and its advantages, as well as the prerequisites,...	Kursus	Læs mere
23.09.2024 18.09.2024	Software as Medical Device and Quality Management The course introduces regulatory requirements that are particularly affecting software as medical device and how they can be...	Kursus	Regulatorisk Læs mere
25.09.2024 20.09.2024	Introduktion til UDI (Unique Device Identification) - Identifikation og mærkning af medicinsk udstyr Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...	Kursus	Innovation Læs mere
01.10.2024 26.09.2024	Mads Koch Hansens velkomstreception	Seminar	Læs mere
02.10.2024 27.09.2024	Training of internal auditors in relation to country specific requirements within the MDSAP program The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...	Kursus	Regulatorisk Læs mere
03.10.2024 29.09.2024	IEC 60601 - How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems How to apply safety and risk management to medical electrical equipment and systems	Kursus	Regulatorisk Læs mere
07.10.2024 01.10.2024	Introduction to Chemical Compliance for Medical Devices The objective is to give participants an understanding of their obligations regarding justification of chemical safety of...	Kursus	Regulatorisk Læs mere
08.10.2024 04.10.2024	Sundhedssystemets opbygning & Market Access Du lærer, hvordan man får medicinsk udstyr ud på det danske marked og ind i det danske sundhedsvæsen	Kursus	Afsætning Læs mere
24.10.2024 17.10.2024	New update on China NMPA Regulation and Registration for Medical Devices with Case Studies You will get a deep understanding of the up-to-date China NMPA regulatory policies	Kursus	Regulatorisk Læs mere
28.10.2024 21.10.2024	Design Control 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
28.10.2024 21.10.2024	MDR Auditing - Training of Internal Auditors in Relation to MDR Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS...	Kursus	Regulatorisk Læs mere
30.10.2024 25.10.2024	Introduktion til medicobranchen Kurset henvender sig bredt til medarbejdere i medicoindustrien, der har brug for indsigt i branchen og en forståelse for de...	Kursus	Regulatorisk Læs mere
05.11.2024 29.10.2024	Clinical Evaluation for Medical Devices in Europe and International Approach Course targeted towards clinical project managers, clinical research associates and others working in the field of clinical...	Kursus	Innovation Læs mere
07.11.2024 01.11.2024	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
11.11.2024 01.11.2024	CQI/IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an...	Kursus	Regulatorisk Læs mere
14.11.2024 11.11.2024	FDA Regulation of Medical Devices: Recent FDA Guidance Documents It is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in...	Kursus	Regulatorisk Læs mere
18.11.2024 11.11.2024	Project Management for Product Development of Medical Devices The course is focused on how to manage the development process for new medical devices and maintaining them in an...	Kursus	Innovation Læs mere
27.11.2024 22.11.2024	ISO 13485 and Quality Management for Medical Devices / Internal Auditing Get an introduction to the ISO 13485:2016 standard and the legislation regarding medical devices. In addition, an insight...	Kursus	Regulatorisk Læs mere
02.12.2024 25.11.2024	Reimbursement as a Driver for Commercial and Clinical Strategies You will be able to direct commercial and clinical strategies towards the development of a market access programme that will...	Kursus	Afsætning Læs mere
03.12.2024 27.11.2024	IEC 62304: Software Lifecycle 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
05.12.2024 30.11.2024	Industrial Sterilization of Medical Devices - Define and Implement Sterilization in Product Development and Manufacturing The key purpose of the course is to make the participants able to make a qualified initial choice of the most suitable...	Kursus	Læs mere
06.12.2024 30.11.2024	Corrective & Preventive Actions (CAPA) This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...	Kursus	Regulatorisk Læs mere
09.12.2024 02.12.2024	Regler om reklame, tilknytning og økonomiske fordele Kurset tager udgangspunkt i de danske reklameregler for medicinsk udstyr og sætter fokus på reglerne for økonomiske fordele...	Kursus	Afsætning Læs mere
10.12.2024 03.12.2024	Introduktion til udbudsloven Et kursus for dig der du brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem i...	Kursus	Regulatorisk Læs mere
12.12.2024 05.12.2024	MDSAP Fundamentals and Readiness Training You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...	Kursus	Regulatorisk Læs mere
16.12.2024 12.12.2024	Introduction to Cybersecurity Risk Management for TIR57 Compliance The course will help build threat modelling concepts and will cover how to do security risk management using the AAMI TIR57...	Kursus	Regulatorisk Læs mere
22.01.2025 20.01.2025	Planning an Effective Post Market Surveillance Program for Medical Devices and Combination Products The purpose of this 1½ day course is to provide you high level details on regulatory requirements on post market...	Kursus	Regulatorisk Læs mere
27.01.2025 23.01.2025	Medical Device Usability The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...	Kursus	Regulatorisk Læs mere
25.03.2025 21.03.2025	Praktisk gennemførelse af risikoanalyser ved produktudvikling Et kursus der henvender sig til personer, der skal medvirke ved gennemførsel af risikoanalyser, og som har behov for et...	Kursus	Innovation Læs mere
28.04.2025 20.04.2025	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Regulatorisk Læs mere
08.05.2025 01.05.2025	Clinical Evaluation for Medical Devices in Europe and International Approach Course targeted towards clinical project managers, clinical research associates and others working in the field of clinical...	Kursus	Regulatorisk Læs mere
28.10.2025 20.10.2025	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Regulatorisk Læs mere
13.11.2025 06.11.2025	Clinical Evaluation for Medical Devices in Europe and International Approach Course targeted towards clinical project managers, clinical research associates and others working in the field of clinical...	Kursus	Regulatorisk Læs mere
20.11.2025 18.11.2025	Medical Device Usability The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...	Kursus	Regulatorisk Læs mere
02.12.2025 28.11.2025	Planning an Effective Post Market Surveillance Program for Medical Devices and Combination Products The purpose of this 1½ day course is to provide you high level details on regulatory requirements on post market...	Kursus	Regulatorisk Læs mere

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MedTech Academy

MedTech Academy