"Thanks again for the quick response… It’s not often the case with auditors, but I would enjoy another visit from you in the future. Thanks again for a great audit!”

-Quality Assurance Manager

Audits are vital and unavoidable in the medical device industry. Internally conducted audits are required and can provide necessary checks and balances on quality systems, confirm that suppliers meet expectations, and prepare companies for external observers. At QA Consulting, our auditors are ASQ Certified Quality Auditors or Exemplar Global Lead Auditors. We provide the required independent and objective party for quality system audits, including:

  • Internal and Supplier Audits (US FDA 21 CFR Part 820; 21 CFR Part 11; ISO 13485; ISO 17025; etc)
  • Sterilization Systems (ISO 11135; ISO 11137; ISO 17655; ISO 14160; etc)
  • Mock FDA Audits
  • Good Laboratory Practices (GLP), including 21 CFR Part 58
  • Compliance Gap Assessments

We are also available to facilitate and/or respond to FDA and Notified Body audits for medical device manufacturers.

* If you do not see your specific audit need listed above, please call us for a more detailed list of services at 512.328.9404

Learn more about our Audit Services