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

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

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

Get an introduction to the ISO 13485:2016 standard and the legislation regarding medical devices as well as an insight into...

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...

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

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

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

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

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

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

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

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

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

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

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

The purpose of this 1½ day course is to provide you high level details on regulatory requirements on post market...

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