In this training program, we will describe and demonstrate the minimum set of cybersecurity testing activities recommended...

In this course we will establish an understanding of the equivalency concept and some potential pitfalls that await...

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

We will provide you with the essential activities which should be performed as part of a robust Security Risk Analysis...

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

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

The course gives you an understanding of the application requirements and the internal processes for application handling at...

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

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

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

The key purpose of the course is to make the participants able to make a qualified initial choice of the most suitable...

The objective is to give participants an understanding of their obligations regarding justification of chemical safety of...

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...

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...

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

BSI will tell about the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR...

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

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

You will get a deep understanding of the up-to-date China CFDA regulatory policies

This one day course will provide a background on Personal Responsible for Regulatory Compliance duties and how this concept...

Efter kurset vil du have et godt udgangspunkt for at vurdere problemstillinger på området for brug af sundhedsdata til...

Et kursus der henvender sig til personer, der skal medvirke ved gennemførsel af risikoanalyser, og som har behov for et...

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...

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

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

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

Dette kursus klæder deltagerne på til at komme i gang med at bruge statistiske værktøjer og få viden om hvad der er "best...

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

Dette ½ dags kursus fokuserer på nogle af de praktiske spørgsmål, der melder sig, når man som tilbudsgiver ønsker at søge...