Audits

Quality Audits are regulatory protocol for all Medical Device companies. They are essential to ensure compliance with associated standards and regulations. Whether verifying the compliance of a key supplier or the proper implementation of own Quality Systems, Top Quality Engineering can complete all of your Quality Auditing needs.

At Top Quality Engineering, we offer ASQ Certified Quality Auditors to conduct Supplier and Internal audits for ISO 13485 and 21 CFR 820 Compliance. With direct experiences within the Medical Device industry and Quality System Requirements (QSRs), all of our CQAs are available to audit your or a supplier’s Quality Systems.