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Highlights

Juli 11, 2023

A New Phase Dawning in MDR Transition – The Sun Is Up!

The last few weeks have made it clear to me that we are entering a new phase of the MDR transition. 
Tag
CE-Kennzeichnung CE-Kennzeichnung erhalten Market Access Europe MDR 2017/745 Verordnung über Medizinprodukte Notified Body
Juli 04, 2023

One year IVDR – certification stress and why you need to act now

Blog by Kristiane Schmidt about the outcome of the Dutch RAPS chapter, focusing on the IVDR and the bottlenecks caused by about 10,000 IVD devices that still need to obtain IVDR certification.
Tag
CE-Kennzeichnung Klinische Daten In-vitro-Diagnostika IVDR Notified Body Techische Dokumentation Highlights

Ergebnisse

September 22, 2023

On-Demand Webinar | Analytical and Clinical Performance for IVDs

In-vitro diagnostics can appear to be even more challenging than 'rocket science', but the reality is that we just need good science. This webinar explores the tools of design control and how to use good science.
Tag
Klinische Angelegenheiten Klinische Daten Klinischer Nachweis Klinische Untersuchung In-vitro-Diagnostika IVDR Regulatorische Angelegenheiten State of Art
September 22, 2023

PDF Download | Analytical and Clinical Performance for IVDs

Tag
Klinische Angelegenheiten Klinische Daten Klinischer Nachweis Klinische Untersuchung In-vitro-Diagnostika IVDR Regulatorische Angelegenheiten State of Art
September 21, 2023

Designing User-Friendly Medical Devices: A Deep Dive into Usability

This blog dives into the importance of usability engineering in the development of medical devices.
Tag
Medizinprodukte Usability Engineering
September 19, 2023

On-Demand Webinar | Navigating Recent 510(k) Updates: Guidance Documents, Recognized Standards, and eSTAR

Learn in this on-demand webinar about upcoming deadlines for standards transitions and eSTAR implementation, and gain clarity on compliance timelines and requirements.
Tag
FDA Verordnung über Medizinprodukte On-Demand Webinar
September 19, 2023

PDF Download | Navigating Recent 510(k) Updates: Guidance Documents, Recognized Standards, and eSTAR

Tag
FDA
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