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

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

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

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

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

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

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

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

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

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

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

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

You will gain a broad insight into the application of AI/ML in the field of medical devices and develop an understanding of...

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

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

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

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

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

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

In this course you will learn the integrated approach of the clinical evaluation process and its important links with risk...

Build secure health software that meets EU and FDA expectations. This course shows you how to apply IEC 81001-5-1 in...

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

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

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

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

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

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