MedTech Academy

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

In this one-hour webinar Intertek’s experts on safety and EMC of electrical medical equipment will explain what the standard...

Få et overblik og indblik i ISO 13485:2016 standarden og lovgivningen vedrørende medicinsk udstyr. Få også viden og...

We will provide you with the essential activities which should be performed as part of a robust Security Risk Analysis...

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

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

På kurset gennemgås de emner, som erfaringsmæssigt giver anledning til særlige udfordringer hos mange virksomheder og med...

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

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...

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

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

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,...

You will learn about the United Nations Global Goals and how to translate global sustainability expectations into your...

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

The course will concentrate on European requirements, in particular the significantly increased PMS requirements under the...

Formålet med kurset er at sætte fokus på, hvilken dialog en leverandør eller potentiel leverandør kan have med ordregiver...

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

The course focus on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your...

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

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

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

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

Dette kursus klæder deltagerne på til at komme i gang med at bruge statistiske værktøjer og få viden om hvad der er "best...

BSI will tell about the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR...

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

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