Quality Audits

"What seems to us as bitter trials are often blessings in disguise" -Oscar Wilde

Quality Audits

 

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:

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FDA Quality System Regulation, 21 CFR Part 820

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ISO 13485/9001

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Medical Device Directive (MDD/IVDD)

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Canadian Medical Device Conformity Assessment (CMDAS/CMDR)

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Supplier Audits

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Due Diligence Assessments

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Sponsor Audits of Clinical Trial Sites

Schedule your required annual quality systems audit with us or arrange for a less formal, gap analysis as a pre-audit preparation activity.

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