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

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

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

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

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 introduction to the ISO 13485:2016 standard and the legislation regarding medical devices. In addition, an insight...

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...

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

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

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