MedTech Academy

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 FDA Pre-Market Guidance for Medical Device Cybersecurity identifies a number of security functions manufacturers should...

Du lærer, hvordan man får medicinsk udstyr ud på det danske marked og ind i det danske sundhedsvæsen

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

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

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

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

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

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

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

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

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

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

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...

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

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

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...