Quality Overview

Dielectrics is ISO 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 13485:2003 certification.