
EU MDR & IVDR Insider | AKRA TEAM
Your monthly resource for EU MDR and IVDR compliance.
Tags: medical devices
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Inside MDSAP: Global Audit Alignment and the Future of Software Compliance
The July Issue of EU MDR & IVDR Insider Is Here
Fresh insights and resources for Medical Device and IVD Manufacturers
This issue covers strategic guidance on global audit alignment through MDSAP, with a special focus on Software as Medical Device (SaMD) and the evolving harmonization landscape.
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by Bassil Akra —
Jul 31, 2025
eu mdr
ivdr
mdsap
medical devices
regulatory affairs
samd
EU Orphan Device Clinical and Regulatory Playbook
Ā
The Second Issue of EU MDR & IVDR Insider is Here
Providing expert insights and practical resources for medical device and IVD manufacturers.
This issue covers the latest updates on orphan devices, critical regulatory changes, and a major initiative that could transform clinical trials in the ...
Feb 28, 2025
akra team
eu mdr
medical devices
orphan device
EU MDR & IVDR Insider | AKRA TEAM

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