Blog
Evangelos MantadakisEUDAMED for Importers: Manufacturers Still Need a Separate Actor
If you already have a manufacturer Actor in EUDAMED and you also import medical devices from outside the EU, that manufacturer SRN is not enough. EUDAMED issues a separate Actor ID / SRN...
Sofia KargiotiNow Available: ISO/IEC 42001:2023 Template for Confluence Cloud
Organizations are adopting artificial intelligence faster than they are documenting how that AI is governed. ISO/IEC 42001:2023 is the international standard for an Artificial Intelligence...
Evangelos MantadakisQC Traceability Is Now on Forge — With More Features for Confluence Cloud
QC Traceability for Confluence Cloud now runs on Atlassian Forge. This is the...
Evangelos MantadakisAuthorised Representative in GreMDIS: What EOF Means — and What It Does Not
When registering medical devices in GreMDIS, the national registry of the National Organization for Medicines (EOF), companies must declare their regulatory role accurately. One of the most...
Evangelos MantadakisMandatory EUDAMED Use from 2026: What Has Changed and How We Can Help
EUDAMED (European Database on Medical Devices) is no longer an optional pilot platform. Following the...
Sofia KargiotiStaying Current: How to Manage the ISO 27001 Climate Action Amendment in Confluence Cloud
With the recent release of the ISO/IEC 27001:2022/Amd 1:2024 amendment , organizations managing an Information Security Management System (ISMS) are facing a...
Evangelos MantadakisCyber Resilience Act and MDR Medical Software: Is It Applicable?
If a company develops medical device software under Regulation (EU) 2017/745 (MDR), does the Cyber Resilience Act,...
Sofia KargiotiHow Our ISO 27001 Template Helped AhoyAhoy Achieve Certification
For many growing tech companies, ISO 27001 certification feels like a major milestone, but also a major mountain to climb. That was exactly the situation facing AhoyAhoy...
Sofia KargiotiQC Status App Migration to Forge and Legacy Server Deactivation
At QC Analytics, we continuously improve our apps to align with Atlassian’s evolving platform and security requirements. As part of this commitment, we would like to inform our users about an...
Sofia KargiotiQC Template Launcher Has Moved to Forge
We would like to inform all users that the QC Template Launcher app was successfully migrated from...