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Why perform Quality Audits?

  • Quality Audits are required by regulation
  • They identify systemic gaps in regulatory compliance
  • Causes of poor product quality may be identified
  • Audits may be leveraged to identify process improvement and cost reduction opportunities

One audit we conducted identified unnecessary inspections at incoming inspection, redundant in-process inspections, and unnecessary device history record reviews. Our recommended savings were in the tens of thousands of dollars per year.

Vision28 can perform audits at your facilities for FDA 21 CFR § 820, ISO 13485:2003, and Canadian Medical Device Regulations (CMDR).

Medical Device Auditing Services:

  • Gap analysis audit – Determine your compliance to the FDA QSR, ISO 13485, and/or Canadian MDR.
  • Pre-assessment audit – Conducted several weeks prior to a Notified Body or Registrar certification audit to prepare for a positive outcome.
  • FDA pre-inspection audit – Identify areas for remediation or strategy development prior to an FDA inspection.
  • FDA inspection – Assist during an actual FDA inspection by managing the “back room”, taking minutes, or even interfacing with FDA.
  • FDA QSR mock audit – There is no better way to prepare your employees for an actual FDA audit than performing FDA mock audits. We will play the role of an aggressive FDA inspector to train your employees on the what to do and what not to do during an inspection to prevent common mistakes that can be catastrophic to your company.
  • Full or partial internal audit – ISO and FDA QSR require that manufacturers conduct regular internal audits of their quality management system. Vision28 provides internal auditing services to allow for an independent review of your full quality system. We can also just focus on specific areas of the quality system where you are most concerned.
  • Subcontractor or supplier audit – Critical suppliers must be “controlled.” This is not only a good business practice, but a regulatory requirement. For example, if your device is manufactured by a contract manufacturer, it is your responsibility to ensure their manufacturing processes meet the appropriate standards and regulations. We will conduct on-site supplier audits on your behalf to ensure that the activities you contracted them for are being executed according to your specifications and applicable regulations.