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六月 10, 2025

Things you need to know about market access in the United Arab Emirates

In the United Arab Emirates (UAE), medical devices are regulated by the Ministry of Health and Prevention (MOHAP). They evaluate the safety and quality of the devices in line with international standards such as U.S. FDA and European CE.
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五月 26, 2025

IVDR 3rd Anniversary – Did you take your foot off the gas? Time to accelerate!

On 26 May 2025 we are celebrating the 3rd anniversary of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices).
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五月 22, 2025

How can you successfully collaborate on MDR with a partner?

As a manufacturer, successful collaboration on the Medical Device Regulation (MDR) with a partner requires clear communication, well-defined expectations, and strategic alignment.
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五月 13, 2025

How do you interpret laws and regulations in your product development to comply with the MDR?

The European Medical Device Regulation(MDR 2017/745) represents one of the most significant regulatory overhauls in the medical device industry. Find out more in our blog!
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五月 09, 2025

New UDI-DI Registration Requirements in Colombia: What Medical Device and IVD Manufacturers Need to Know

In an effort to align with global best practices and strengthen the traceability and safety of Medical Devices (MD) and In Vitro Diagnostic (IVD) Devices, Colombia has introduced new requirements. Read about it in our blog. 
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