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

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

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

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

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

The course aims to provide a plan for how to build a cybersecurity framework holistically

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

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...

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

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

The course introduces the most important changes of the Medical Device Directive (MDD) to the new Medical Devices Regulation...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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