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.
Analysis
Qapsule: a Ketryx alternative for SaMD teams
SaMD shortlist criteria: stack, eQMS in your tools, MDR/IVDR evidence. Market reference table included.
Analysis
AI Act and medical devices: what SaMD manufacturers should prepare now
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
PCCP and AI medical software: governing change without slowing the product
How to prepare a Predetermined Change Control Plan aligned with the QMS, software lifecycle and FDA / MDSAP expectations.
Article
IEC 81001-5-1 and MDR: folding cybersecurity into the software lifecycle
Connect threat modeling, SBOM and evidence to the technical file, so cyber is not an add-on outside the QMS.
Article
ISO 13485 QMS after QMSR: what MDSAP changes for European MedTechs
An operational reading of FDA QMSR / ISO 13485 alignment and MDSAP implications for manufacturers also targeting the United States.