Quality Systems

xFDA can supply you with the appropriate FDA conforming documentation and training. Our Quality System solutions are tailored for your organization.

Medical Devices/In Vitro Test Kits: xFDA can organize and execute an entire system or a particular subsystem to meet the FDA QSR compliance.

Inspections: Our approach to cGMP quality system implementation for biologic and pharmaceutical manufacturers (21 CFR Part 210 and 211) complies with FDA's Compliance Program.

Contact us today for a non-obligatory consultation. Let's discuss your needs and scope of any quality system implementation or improvement project.