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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/MDSW%20for%20Start-ups%20A%20Practical%20Guide%20to%20Compliant%20Medical%20Software%20Development.jpg

MDSW for Start-ups: A Practical Guide to Compliant Medical Software Development

Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for start-ups with limited resources. But here’s the good news:...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/UDI-for-software-how-to-mark-your-MDSW-with-a-UDI-QbD-Group-1.jpg

UDI for software: how to mark your MDSW with a UDI?

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefly explains what a UDI is and how to implement it on...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Website%202025%20-%20Pictures/Blog%20-%20MDR%20impact%20on%20MDSW%20-%20what%20has%20changed%20from%20MDD%20-%20QbD%20Group.jpg

MDR impact on MDSW: what has changed from MDD?

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/SaMD-versus-MDSW-whats-the-difference-between-Software-as-a-Medical-Device-and-Medical-Device-SoftWare-1536x864.jpg

SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support,...
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