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

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

This course gives you an introduction to incentive programs in general, especially do’s and don’ts in connection with...

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

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

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

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

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...

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

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

BSI will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the General...

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...

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

Du får overordnet viden om og forståelse for den menneskelige organismes opbygning og funktion hos raske og syge mennesker.

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

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

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

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

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

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

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

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

The course will concentrate on European requirements, in particular the significantly increased PMS requirements under the...

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

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

Course targeted towards clinical project managers, clinical research associates and others working in the field of clinical...

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

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

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

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

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