About Us

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

Quality Assurance

  • 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