MedTech Academy

Learn how you can enter the rapidly growing Chinese healthcare market for medical devices via preferential policies in...

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

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

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...

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...

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

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

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...

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

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

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

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...

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

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

Kurset fokuserer på nogle af de praktiske spørgsmål, der melder sig, når man som tilbudsgiver ønsker at søge...