Comprehensive training covering MDR 2017/745 essentials, including device classification, conformity routes, QMS, GSPRs, PSURs, and working with Notified Bodies.
Understanding FDA’s new Quality Management System Regulation and transition guidance from 21 CFR 820 or ISO 13485.
Save 20+ hours with compliance tools trusted by medical device teams.
We offer customized packages for startups, manufacturers, and consultants preparing for audits or refining QMS processes with proven internal audit tools and expert training.
To ensure compliance and stay up to date with regulatory requirements, our training and internal QMS tools reference key standards and regulations, including:
