VALIDATION AND
ISO CERTIFICATIONS

ESI recently upgraded its ISO standards. We have also recently completed several Validation protocols. These Validations meet the most stringent objectives required by the FDA concerning Special Process validation.

At ESI, we are committed to meeting our customers' expectations for the quality of the products and services that we provide.

ISO CERTIFICATIONS

May 21, 2010 - We have been assessed and certified by National Quality Assurance, U.S.A. against the provisions of ISO 9001:2008 and ISO13485:2003.

Read our Certification letter

VALIDATION

July 9, 2010 - ESI has conducted a thorough review and validation of our cleaning, passivation, electropolishing and anodizing processes. These processes were validated to determine their performance against Cytotoxicity, Bioburden, Endotoxicity, and Particulate Accumulation testing.

Read our Validation letter