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...

You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...

It is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in...

This course will tell about the key changes to requirements for CE marking following the publication of the new IVD...

Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...

This course will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the...

Du bliver i stand til at mestre reglerne inden for digital markedsføring af medicinsk udstyr. Du lærer at identificere...

This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an...

The course introduces the most important changes of the Medical Device Directive (MDD) to the new Medical Devices Regulation...

The course is focused on the regulatory challenges for combination products and will give a detailed description of the...

The purpose of this course is to provide you a high-level overview of relevant rules to consider when structuring a...

The purpose of this course is to provide you a high-level overview of relevant rules to consider when structuring a...

How to apply safety and risk management to medical electrical equipment and systems

Ledelsen, herunder bestyrelsen og direktionen, skal blandt andet følge relevant uddannelse for at opnå kompetencer til at...

The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...

The course is focused on how to manage the development process for new medical devices and maintaining them in an...

The participants will achieve an understanding of how to document the usability of medical devices in order to achieve...

MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...

This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design...

Kurset giver et bredt overblik over de regulatoriske aspekter, som knytter sig til medicinsk udstyr og medicinsk udstyr til...

Et kursus for dig der har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...

The course introduces regulatory requirements that are particularly affecting software as medical device and how they can be...

På kurset gennemgås de emner, som erfaringsmæssigt giver anledning til særlige udfordringer hos mange virksomheder og med...

You will gain experience with articulating threats in a threat model, how to apply tools like MITRE ATT...

The course focuses on the newly published Quality Management System Regulation (QMSR) that replaces the Quality System...

BSI will learn you how to create robust technical documentation to demonstrate compliance to the MDR and better understand...

Målgruppen for kurset er primært medarbejdere, der beskæftiger sig med logistiske processer inden for fx mærkning, pakning,...

How to apply safety and risk management to medical electrical equipment and systems

Kurset henvender sig bredt til medarbejdere i medicoindustrien, der har brug for indsigt i branchen og en forståelse for de...

Every company producing medical devices needs to understand how to practically accomplish process validation

The course is focused on how to manage the development process for new medical devices and maintaining them in an...

Du lærer, hvordan man får medicinsk udstyr ud på det danske marked og ind i det danske sundhedsvæsen

This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design...

Kurset tager udgangspunkt i de danske reklameregler for medicinsk udstyr og sætter fokus på reglerne for økonomiske fordele...

Et kursus for dig der har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...

It is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in...

You will be able to direct commercial and clinical strategies towards the development of a market access programme that will...