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

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

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

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

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

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

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

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

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

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

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

The participants will be trained in toxicological assessment of substances in compliance with ISO10993-17:2023

You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...

The long-awaited final rule has been published. In this webinar you will learn about the harmonization effort by FDA versus...

You will increase your knowledge of the guidelines for conducting MDSAP regulatory audits and the skills needed within your...

The objective is to give participants an understanding of their obligations regarding justification of chemical safety of...

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

The course will present and assist understanding of the differences between the US and European medical device regulations

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

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

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

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