MedTech Academy

Læs mere om Medicoindustriens kurser, uddannelse og seminarer

Startdato	Emne	Type	Arbejdsområde
23.08.2021 16.08.2021	Medtech Market Access Officer 2021 (tidl. Medicokonsulent) Uddannelsen er målrettet salgs- og marketingmedarbejdere i medicoindustrien. Formålet med uddannelsen er at gøre deltagerne...	Uddannelse	Læs mere
06.10.2021 04.10.2021	MedTech RA Officer 2021 MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...	Uddannelse	Regulatorisk Læs mere
12.10.2021 05.10.2021	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
25.10.2021 20.10.2021	Implementation of the IVDR for CE Marking BSI will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the General...	Kursus	Regulatorisk Læs mere
25.10.2021 19.10.2021	Implementation of the MDR for CE Marking The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your...	Kursus	Regulatorisk Læs mere
28.10.2021 25.10.2021	GDPR - praktiske udfordringer for medicovirksomheder På kurset gennemgås de emner, som erfaringsmæssigt giver anledning til særlige udfordringer hos mange virksomheder og med...	Kursus	Regulatorisk Læs mere
29.10.2021 24.10.2021	Biological Equivalence and Global Compliance - Implementation of ISO 10993 This new course takes a deeper dive into two key areas; understanding and applying MDR requirements for demonstrating...	Kursus	Regulatorisk Læs mere
01.11.2021 27.10.2021	ISO 13485 and Quality Management for Medical Devices / Internal Auditing Få et overblik og indblik i ISO 13485:2016 standarden og lovgivningen vedrørende medicinsk udstyr. Få også viden og...	Kursus	Regulatorisk Læs mere
04.11.2021 02.11.2021	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
05.11.2021 29.10.2021	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
10.11.2021 03.11.2021	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
12.11.2021 05.11.2021	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
15.11.2021 12.11.2021	MDD to MDR Transition BSI will tell you about the key changes in the transition from MDD to the new MDR - you will learn to identify the next...	Kursus	Regulatorisk Læs mere
16.11.2021 08.11.2021	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
18.11.2021 15.11.2021	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
22.11.2021 18.11.2021	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
22.11.2021 12.11.2021	Medtech Summit - Sundhedsaftalens konsekvenser for det danske marked	Seminar	Læs mere
29.11.2021 22.11.2021	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
06.12.2021 29.11.2021	Statistik for procesvalidering Dette kursus klæder deltagerne på til at komme i gang med at bruge statistiske værktøjer og få viden om hvad der er "best...	Kursus	Innovation Læs mere
08.12.2021 01.12.2021	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
08.12.2021 02.12.2021	IVDD to IVDR Transition BSI will tell about the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR...	Kursus	Regulatorisk Læs mere
10.12.2021 05.12.2021	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
13.12.2021 06.12.2021	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
14.12.2021 07.12.2021	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
15.12.2021 08.12.2021	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
16.12.2021 09.12.2021	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
22.12.2021 15.12.2021	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	Afsætning Læs mere
06.01.2022 02.01.2022	Planning an Effective Post Market Surveillance Program for Medical Devices The course will concentrate on European requirements, in particular the significantly increased PMS requirements under the...	Kursus	Regulatorisk Læs mere
12.01.2022 10.01.2022	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
12.01.2022 10.01.2022	Economic Operators The participants will achieve an understanding of the new obligations to medical device Economic Operators according to the...	Kursus	Regulatorisk Læs mere
13.01.2022 11.01.2022	DNV Product Assurance (DNV GL Presafe) - How to Apply for MDR Certification The course gives you an understanding of the application requirements and the internal processes for application handling at...	Kursus	Regulatorisk Læs mere
02.02.2022 28.01.2022	MDD to MDR Transition BSI will tell you about the key changes in the transition from MDD to the new MDR - you will learn to identify the next...	Kursus	Regulatorisk Læs mere
04.02.2022 01.02.2022	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	Regulatorisk Læs mere
07.02.2022 02.02.2022	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
14.03.2022 10.03.2022	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
21.03.2022 16.03.2022	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
24.03.2022 22.03.2022	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
30.03.2022 27.03.2022	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
11.04.2022 06.04.2022	Implementation of the IVDR for CE Marking BSI will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the General...	Kursus	Regulatorisk Læs mere
11.04.2022 06.04.2022	Implementation of the MDR for CE Marking The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your...	Kursus	Regulatorisk Læs mere
05.05.2022 02.05.2022	MedTech RA Officer 2022 MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...	Uddannelse	Regulatorisk Læs mere
09.05.2022 07.05.2022	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
11.05.2022 06.05.2022	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
03.06.2022 01.06.2022	GDPR - praktiske udfordringer for medicovirksomheder På kurset gennemgås de emner, som erfaringsmæssigt giver anledning til særlige udfordringer hos mange virksomheder og med...	Kursus	Regulatorisk Læs mere
16.06.2022 13.06.2022	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
16.06.2022 14.06.2022	IVDD to IVDR Transition BSI will tell about the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR...	Kursus	Regulatorisk Læs mere
20.06.2022 16.06.2022	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	Afsætning Læs mere
01.09.2022 28.08.2022	Quality Systems Regulations (QSR) The course will present and assist understanding of the differences between the US and European medical device standards.	Kursus	Regulatorisk Læs mere
02.09.2022 30.08.2022	Personlig beskyttelse for teknikere - afbrydelse af smitteveje Hygiejnekursus bestående af 2 dele: Generel hygiejne & Strålehygiejne	Kursus	Læs mere
05.09.2022 01.09.2022	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
06.09.2022 03.09.2022	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	Regulatorisk Læs mere
07.09.2022 05.09.2022	MDD to MDR Transition BSI will tell you about the key changes in the transition from MDD to the new MDR - you will learn to identify the next...	Kursus	Regulatorisk Læs mere
09.09.2022 06.09.2022	Beskyt din virksomheds ideer: Patenter, forretningshemmeligheder og forskningssamarbejder i medicobranchen Forstå patentretlige regler, fokuspunkter ved indgåelse af forskningssamarbejder og fortrolighedsaftaler og hvorledes en...	Kursus	Regulatorisk Læs mere
09.09.2022 06.09.2022	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
15.09.2022 13.09.2022	Sustainability in Medtech Companies – Accelerating Your Impact You will learn about the United Nations Global Goals and how to translate global sustainability expectations into your...	Kursus	Innovation Læs mere
28.09.2022 26.09.2022	Incentive Programs - Learn How to Decide, Implement and Maintain the Right Program in Your Company This course gives you an introduction to incentive programs in general, especially do’s and don’ts in connection with...	Kursus	Regulatorisk Læs mere
05.10.2022 03.10.2022	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
10.10.2022 05.10.2022	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
12.10.2022 10.10.2022	Implementation of the IVDR for CE Marking BSI will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the General...	Kursus	Regulatorisk Læs mere
12.10.2022 10.10.2022	Implementation of the MDR for CE Marking The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your...	Kursus	Regulatorisk Læs mere
20.10.2022 17.10.2022	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
01.11.2022 29.10.2022	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
10.11.2022 07.11.2022	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
21.11.2022 17.11.2022	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
05.12.2022 01.12.2022	Planning an Effective Post Market Surveillance Program for Medical Devices The course will concentrate on European requirements, in particular the significantly increased PMS requirements under the...	Kursus	Regulatorisk Læs mere
07.12.2022 05.12.2022	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
08.12.2022 06.12.2022	IVDD to IVDR Transition BSI will tell about the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR...	Kursus	Regulatorisk Læs mere
08.12.2022 05.12.2022	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
13.12.2022 09.12.2022	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	Afsætning Læs mere
15.12.2022 13.12.2022	Statistik for procesvalidering Dette kursus klæder deltagerne på til at komme i gang med at bruge statistiske værktøjer og få viden om hvad der er "best...	Kursus	Innovation Læs mere
19.12.2022 14.12.2022	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

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MedTech Academy