Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Manufacturers |
| Work | CGMP audits, quality-system review and product traceability |
| Rules and standards | Product-specific CGMP; device QMSR in 21 CFR Part 820 |
The FDA Quality Management System Regulation (QMSR) took effect on February 2, 2026. Read the FDA QMSR requirements.
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Our cGMP audit service reviews quality systems and product traceability. Our experienced auditors can identify cGMP non-compliance risks so you can correct them before regulatory inspections.
Service information adapted from the original source ↗.
Read the original website record