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

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

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

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

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

This one-day course is designed for professionals who are already familiar with ISO 9001 and want to understand the...

Build a stronger clinical evidence strategy across the entire medical device lifecycle. This two-day course shows how...

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

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

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...

The course will thoroughly cover and explain the key areas that manufacturers, importers, and distributors need to...

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 har brug for at få helt styr på udbudsreglerne og ønsker et overblik over, hvordan man skal bruge dem...

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,...

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...

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

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...

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 NMPA regulatory policies.

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

During the last years the request and requirements on PMS has increased and more is in the ISO 13485:2016 and the new...

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.

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

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

This two-day course provides hands-on methods for managing the risk of harm to patients, users and others, in development...

The course is based on the Danish advertising rules for medical devices and focuses on the regulations concerning financial...

You will understand the technical documentation requirements as specified in the MDR and relevant guidance documentation and...

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

The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the...

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