MedTech Academy

Læs mere om Medicoindustriens kurser, uddannelse og seminarer

Startdato	Emne	Type	Arbejdsområde
13.01.2020 06.01.2020	Medicokonsulent 2020 Medicokonsulentuddannelsen er en uddannelse for salgs- og marketingmedarbejdere i medicoindustrien. Formålet med uddannelsen...	Uddannelse	Læs mere
09.03.2020 10.09.2020	MedTech RA Officer 2020 MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...	Uddannelse	Regulatorisk Læs mere
30.03.2020 23.03.2020	ISO 13485 and Quality Management for Medical Devices / Internal Auditing The course consists of two parts: Quality management for Medical Devices and ISO 13485 (2 days)...	Kursus	Regulatorisk Læs mere
03.04.2020 31.03.2020	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
22.04.2020 17.04.2020	Introduktion til medicobranchen "Godt sammensat med forskellige relevante emner, der giver en god introduktion til medicoindustrien. Gode undervisere fra...	Kursus	Regulatorisk Læs mere
29.04.2020 24.04.2020	Economic Operators The participants will achieve an understanding of the new obligations to medical device Economic Operators according to the...	Kursus	Regulatorisk Læs mere
04.05.2020 27.04.2020	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
04.05.2020 29.04.2020	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
13.05.2020 07.05.2020	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
15.05.2020 12.05.2020	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
18.05.2020 14.05.2020	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
25.05.2020 18.05.2020	Medical Device Cybersecurity Testing for Regulatory Compliance In this training program, we will describe and demonstrate the minimum set of cybersecurity testing activities recommended...	Kursus	Regulatorisk Læs mere
26.05.2020 20.05.2020	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
27.05.2020 22.05.2020	Cybersecurity Risk Management & Introduction to AAMI TIR57 We will provide you with the essential activities which should be performed as part of a robust Security Risk Analysis...	Kursus	Regulatorisk Læs mere
02.06.2020 27.05.2020	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
03.06.2020 28.05.2020	EN 60601-series - 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
08.06.2020 02.06.2020	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
11.06.2020 08.06.2020	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
15.06.2020 11.06.2020	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
15.06.2020 10.06.2020	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
16.06.2020 10.06.2020	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
17.06.2020 15.06.2020	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
24.08.2020 17.08.2020	Project Management for Product Development of Medical Devices This four day course focuses on project management, and includes references to terms, standards, tools and techniques from...	Kursus	Innovation Læs mere
25.08.2020 20.08.2020	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
27.08.2020 24.08.2020	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
01.09.2020 24.08.2020	ISO 13485 and Quality Management for Medical Devices / Internal Auditing The course consists of two parts: Quality management for Medical Devices and ISO 13485 (2 days)...	Kursus	Regulatorisk Læs mere
02.09.2020 28.08.2020	Personlig beskyttelse for teknikere - afbrydelse af smitteveje Hygiejnekursus bestående af 2 dele: Generel hygiejne & Strålehygiejne	Kursus	Læs mere
03.09.2020 31.08.2020	Persondatareglerne i praksis På kurset gennemgås de opgaver, som bør prioriteres, dels i forhold til opfyldelse af lovens krav og dels i forhold til de...	Kursus	Regulatorisk Læs mere
04.09.2020 02.09.2020	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
04.09.2020 01.09.2020	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
07.09.2020 28.08.2020	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
08.09.2020 03.09.2020	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
10.09.2020 07.09.2020	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
24.09.2020 21.09.2020	CE mærkning af medicinsk udstyr Få forståelse for og overblik over de krav og elementer, der indgår i CE-mærkningen for medicinsk udstyr	Kursus	Regulatorisk Læs mere
25.09.2020 22.09.2020	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
28.09.2020 21.09.2020	ISO 13485 and Quality Management for Medical Devices / Internal Auditing The course consists of two parts: Quality management for Medical Devices and ISO 13485 (2 days)...	Kursus	Regulatorisk Læs mere
29.09.2020 23.09.2020	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
01.10.2020 28.09.2020	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
05.10.2020 30.09.2020	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
06.10.2020 01.10.2020	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
07.10.2020 05.10.2020	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
20.10.2020 15.10.2020	Introduktion til medicobranchen "Det fungerer rigtig godt, at der bliver gennemgået så mange forskellige områder indenfor medicobranchen - det giver et...	Kursus	Regulatorisk Læs mere
23.10.2020 20.10.2020	Economic Operators The participants will achieve an understanding of the new obligations to medical device Economic Operators according to the...	Kursus	Regulatorisk Læs mere
26.10.2020 22.10.2020	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
28.10.2020 23.10.2020	Dialog med ordregiver i udbud – hvor går grænsen? Formålet med kurset er at sætte fokus på, hvilken dialog en leverandør eller potentiel leverandør kan have med ordregiver...	Kursus	Regulatorisk Læs mere
02.11.2020 26.10.2020	Project Management for Product Development of Medical Devices This four day course focuses on project management, and includes references to terms, standards, tools and techniques from...	Kursus	Innovation Læs mere
09.11.2020 04.11.2020	Process Validation Every company producing medical devices needs to understand how to practically accomplish process validation	Kursus	Innovation Læs mere
11.11.2020 06.11.2020	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
13.11.2020 10.11.2020	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
16.11.2020 11.11.2020	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
18.11.2020 13.11.2020	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
26.11.2020 23.11.2020	New Update on China CFDA Regulation and Registration for Medical Devices with Case Studies You will get a deep understanding of the up-to-date China CFDA regulatory policies	Kursus	Regulatorisk Læs mere
30.11.2020 26.11.2020	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
01.12.2020 26.11.2020	EN 60601-series - 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
01.12.2020 27.11.2020	Præsentationsteknik - forøg din gennemslagskraft Kursus for alle som i hverdagen præsenterer budskaber til både personer og grupper, og som ønsker at få endnu mere power,...	Kursus	Afsætning Læs mere
03.12.2020 30.11.2020	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
07.12.2020 02.12.2020	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
08.12.2020 03.12.2020	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
18.12.2020 15.12.2020	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

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MedTech Academy