Quality & Regulatory

We bring validation preparation and execution capabilities implementing your quality system or ours, abiding by current Good Manufacturing Practices (cGMP) regulations: CFR 820, 210, 211, and Part 4 as applicable, and/or ISO13485 requirements. Providing repeatable and predictable plans around validation activity so that you can manufacture with confidence and compliance.

IQ - OQ - PQ - FAT - SAT

Metrology

Quality & Regulatory

Metrology services are provided by experienced staff using calibrated equipment traceable to NIST standards:

Our metrology equipment features:

State-of-the-art Keyence IM8000 Vision system
A programmable Micro-Hite CMM with PC-DMIS,
Multiple Micro-Hite digital height gauges
CCP CC-14 Comparator,
Chatillon Test Stands and Force Gauges
Multimeters
Durometers
Vast assortment of specialized inspection hand tools, gauge pins and blocks.

Quality & Regulatory