Quality Overview

Dielectrics is ISO 9001:2008, 13485:2003 Certified, and FDA registered (#1220351)

Based on your product specifications and Dielectrics' expertise, a customized quality plan will be developed for your product(s). Dielectrics will assist their clients in establishing an appropriate risk management and validation strategy. The quality plan will include:

Manufacturing operational specifications (MOS)
Device history record (DHR) master templates
Inspection and test requirements
Label control and reconciliation

Please click on the link to view our ISO 9001:2008 and ISO 13485:2003 certifications.