Many organizations view quality audits as a major disruption and a non-value added activity. However, when quality audits are conducted at regular intervals by an experienced auditor, a quality audit can be a tremendous feedback mechanism to identify broken processes and potential compliance trouble spots. If issues are identified early enough, then potential regulatory actions and future product problems can be avoided.
Our experienced team can perform your required annual quality system audit to satisfy applicable regulatory obligations. During our assessment, we will also provide feedback on those items, which may not be a clear violation, but may turn into something more serious if not addressed.
We can assist with the following types of audits:
FDA Quality System Regulation, 21 CFR Part 820
Medical Device Directive (MDD/IVDD)
Canadian Medical Device Conformity Assessment (CMDAS/CMDR)
Due Diligence Assessments
Sponsor Audits of Clinical Trial Sites