MedTech Academy

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

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

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

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

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

BSI will tell you about the key changes in the transition from MDD to the new MDR - you will learn to identify the next...

BSI will tell about the IVD classification rules and the conformity assessment routes. Learn the importance of the General...

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

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

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

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

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

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

Kursus for alle som i hverdagen præsenterer budskaber til både personer og grupper, og som ønsker at få endnu mere power,...

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

In this training program, we will describe and demonstrate the minimum set of cybersecurity testing activities recommended...

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

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

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

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

Få forståelse for og overblik over de krav og elementer, der indgår i CE-mærkningen for medicinsk udstyr

This course gives you an introduction to incentive programs in general, especially do’s and don’ts in connection with...

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

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

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...

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

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...