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June 13, 2025

AI Compliance foundation for medical devices

Artificial intelligence (AI) has become integral to many medical devices in today's rapidly evolving technological landscape. However, organizations integrating AI capabilities in healthcare products often underestimate the regulatory implications, creating significant business risks.
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June 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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May 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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May 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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May 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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