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

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

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

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

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

The course is focused on how to manage the development process for new medical devices and maintaining them in an...

The course is focused on how to manage the development process for new medical devices and maintaining them in an...

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

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

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

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

Du får et overblik over relevant databeskyttelsesret, herunder GDPR og særlovgivning, og hvordan reglerne anvendes i praksis...

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...

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

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

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

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

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

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

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

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

The purpose of the course is to use risk-based approaches to understand how to perform evaluations and what additional...

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

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

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

The course is focused on the regulatory challenges for combination products and will give a detailed description of the...

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