About Us

Qualifications and Certifications

Ethide Labs follows a rigorous certification program to be ISO 13485:2003 registered for microbiological, biological and ethylene oxide residual testing for the medical device industry
We are active members of American Society for Microbiology
We are involved with the Association for the Advancement of the Medical Instrumentation (AAMI), Society for Industrial Microbiology (SIM), Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineering (ISPE)
All technical staff are degreed scientists
Ethide brings a wealth of experience having over 50 years in the medical device and allied industries

All scientists receive annual training and proficiency qualification in their areas of responsibility
Staff routinely participates in regional and national association meetings to keep up on cutting edge developments in the industry
Laboratory equipment is on a routine documented maintenance and calibration program
Rigorous internal audits for key processes are conducted regularly by qualified personnel
Audits by independent auditors and international notified bodies are performed routinely
Defined test procedures have been developed referencing current national and international protocols to ensure valid test data
All test reports are reviewed by an analyst and quality management staff for accuracy
All test reports are archived for five years at which time the customer can choose to have the archives shipped to them