
EU MDR & IVDR Insider | AKRA TEAM
Your monthly resource for EU MDR and IVDR compliance.
Tags: mdsap
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CAPA Fundamentals: From Compliance to Prevention
EU MDR & IVDR Insider
September 2025 Issue
A free publication from AKRA TEAM
UPDATE
Welcome to the September Issue of EU MDR & IVDR InsiderUpdate by Bassil Akra, PhD
INSIGHTS
- CAPA Fundamentals: From Compliance to Prevention
with Anna Spehl โ AKRA TEAM
- 9 CAPA Essentials Reviewers Expect
wit...
by Anna Spehl, Azam Khorshidi, Bassil Akra, Zaher Kharboutly โ
Sep 29, 2025
capa
eu mdr
ivdr
mdsap
medical devices
pms
qms
regulatory affairs
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.
...
by Bassil Akra โ
Jul 31, 2025
eu mdr
ivdr
mdsap
medical devices
regulatory affairs
samd
EU MDR & IVDR Insider | AKRA TEAM

Your monthly resource for EU MDR and IVDR compliance.
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