Resources
Guides and landmarks to move faster
Resources to structure your compliance and inform your decisions, helping you understand, anticipate and master your software compliance through analyses and methods designed to accelerate lasting conformity.
Guide
EUDAMED since 2026: where to find the info and how to prepare your registration
Mandatory, but opaque: where to find the info, what to prepare before filing a medical device, and how to limit round-trips (BEUDAMED, DM Atlas).
Guide
How to manage SOUP, SBOM, and the CRA on a DM + wellness portfolio
SOUP inventory, living SBOM and CRA: team routines, evidence and release gates without forced ALM migration.
Analysis
eQMS vs ALM vs compliance infrastructure: untangle the categories
Clarify eQMS, ALM and compliance infrastructure for SaMD: roles, boundaries and where an overlay like Qapsule fits.
Guide
IEC 62304 with Jira and GitHub: apply the SaMD software lifecycle
Connect IEC 62304 to Jira and GitHub: processes, A/B/C classes, SOUP, evidence and traceability, without migrating to an ALM suite.
Analysis
IEC 62304 Edition 2: where does the revision really stand?
CD2 circulated, comment resolution from 19 August 2026, publication targeted for 2028. Classes, cloud and AI: what QA/RA should watch.
Analysis
Qapsule vs Ketryx and alternatives: which compliance layer for SaMD?
Which compliance layer for SaMD: existing stack, eQMS in your tools, MDR/IVDR evidence. Market reference table included.
Analysis
AI Act and SaMD: what to prepare before 2028?
How to connect the AI Act and MDR/IVDR without duplicating the file, by extending the existing QMS to data, monitoring and human oversight.
Analysis
FDA PCCP for AI medical software: framing modifications
How to prepare a Predetermined Change Control Plan aligned with the QMS, software lifecycle and FDA / MDSAP expectations.
Guide
IEC 81001-5-1 and MDR: integrating cybersecurity into the lifecycle
Connect threat modeling, SBOM and evidence to the technical file, so cyber is not an add-on outside the QMS.
Guide
ISO 13485, QMSR and MDSAP: how to build a single QMS for Europe and the United States?
An operational reading of FDA QMSR / ISO 13485 alignment and MDSAP implications for manufacturers also targeting the United States.