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février 20, 2023

Medical Device and IVD Software Development – From Aerobatics to Formation Flying!

Paul Hoseit: 'My dad used to say, there are old pilots and there are bold pilots but there are not many old, bold pilots. For this blog we can substitute pilots for medical device (MD) & in-vitro diagnostic (IVD) programmers.'

In-Vitro Diagnostics Medical Devices Software Highlights

Résultats

News flash | UK additional consultation & innovative pathway

On the 26th of May, there are two updates from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Highlights In-Vitro Diagnostics Medical Device Regulations Medical Devices MHRA Regulatory Affairs UKCA

Free Webinar PDF Download | EU-IVDR one year on!

In-Vitro Diagnostics IVDR Webinaire

On-Demand Webinar | EU-IVDR one year on!

Europe In-Vitro Diagnostics IVDR Regulatory Affairs Webinaire

Things You Should Know About Medical Device Registration in Singapore

Expanding to Singapore before entering other ASEAN markets is often considered a first step to build up business in the ASEAN region. Read more about the general regulatory requirements, evaluation routes and developments in Singapore.

Medical Device Regulations Medical Devices QA/RA Regulatory Affairs Regulatory Compliance Regulatory strategy Singapore Highlights

Update on the Knows and Dos for innovation pathway

The innovation pathway to China, one of the three routes which are the basis for a fast-track review system in China, learn more about the Knows and Dos for innovation pathway.

China Medical Device Regulations NMPA Regulatory Affairs

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