Ledelsen, herunder bestyrelsen og direktionen, skal blandt andet følge relevant uddannelse for at opnå kompetencer til at...

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

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

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

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

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

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

På kurset gennemgås seneste nyt om det udvidet producentansvar for emballage (EPR), herunder de konsekvenser, det vil få for...

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

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

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

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

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

This course aims to offer guidance on implementation of the requirements stipulated in the MDR.

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

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

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

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...

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

Get an overview and insight into the ISO 13485:2016 standard and the legislation regarding medical devices. Also gain...

This course will tell about the key changes to requirements for CE marking following the publication of the new IVD...

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

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

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

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

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

Forstå patentretlige regler, fokuspunkter ved indgåelse af forskningssamarbejder og fortrolighedsaftaler og hvorledes en...

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

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

Et kursus der henvender sig til personer, der skal medvirke ved gennemførsel af risikoanalyser, og som har behov for et...

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

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

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

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

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

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

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

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

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

Dette ½ dags kursus fokuserer på nogle af de praktiske spørgsmål, der melder sig, når man som tilbudsgiver ønsker at søge...

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