Introducing Digital QMS Toolkits for SaMD Startups
May 29, 2024
Focus area
Quality Systems for SaMD and Health-tech
Quality systems for medical device and SaMD teams: ISO 13485 and QMSR, V&V, risk management and validation of the software tools your QMS runs on.
How we help
QMS setup and audits
ISO 13485 and QMSR-aligned procedures sized for a small team, plus internal audits and inspection readiness.
Software lifecycle and risk
IEC 62304 processes and ISO 14971 risk files, including AI-specific and cybersecurity hazards.
V&V planning and testing
Verification and validation plans, test protocols and execution, with traceable reports for your submission.
QMS tool validation
Risk-based validation of eQMS and other quality software under CSA and 21 CFR Part 11, including AI and agentic tools.
