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

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

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

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

The course will help build threat modelling concepts and will cover how to do security risk management using the AAMI TIR57...

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

This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...

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...

Forstå patentretlige regler, fokuspunkter ved indgåelse af forskningssamarbejder og fortrolighedsaftaler og hvorledes en...

Kursets overordnede formål er at give dig praktiske redskaber til at udarbejde robuste brugervejledninger, som lever op til...

This course aims to offer guidance on implementation of the requirements stipulated in the MDR.

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

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

Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS...

Dette ½ dags kursus fokuserer på de situationer, hvor salg kan ske til det offentlige, uden at der forudgående er gennemført...

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

The course aims to provide a plan for how to build a cybersecurity framework holistically

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

The course will help build threat modelling concepts and will cover how to do security risk management using the AAMI TIR57...

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

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...

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

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

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

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...

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

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

The course will present and assist understanding of the differences between the US and European medical device regulations

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

You will be provided a structured roadmap to process the complex commercial and regulatory elements needed to gain success...

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

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 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

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

Get an overview and insight into the ISO 13485:2016 standard and the legislation regarding medical devices. Also gain...

This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of a software as...

This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective...

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...