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

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

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...

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

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

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

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

MedTech RA Officer er en uddannelse, der give dig et bredt overblik over de regulatoriske aspekter, som knytter sig til...

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...

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

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

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

This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an...

This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an...

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

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

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

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

This course will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the...

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

It is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in...

The purpose of this course is to provide you a high-level overview of relevant rules to consider when structuring a...

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

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...

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