Medical Device Gap, Internal, Pre-Certification and Supplier QMS Audits

Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards. Failure to do so can result in poor product quality, loss of certification or lack of process improvement. Medical device companies often ask us to conduct Quality Management System compliance audits and/or audits of their system to ensure compliance with the FDA Quality System Regulation (FDA QSR – 21 CFR Part 820), ISO 13485:2016, Japan Ministerial Ordinance 169, Korea GMP, Brazilian GMP and Canadian Medical Device Regulations (CMDR). We typically perform medical device QMS audits for companies because they do not have the resources or expertise to conduct them, or they prefer having an independent company do internal audits to ensure unbiased results.

Interested in upgrading to ISO 13485:2016? See how we can help.

QMS auditing services we offer:

  1. Gap analysis audit - This is an audit in which we will determine your current level of compliance with the appropriate quality regulations including FDA QSR (21 CFR Part 820), ISO 13485:2016, Japan Ordinance 169, Korea GMP, Brazilian GMP and/or Canadian MDR. The gap analysis is typically conducted before a system is implemented to identify areas of deficiency.
  2. Pre-assessment audit - We highly recommend that a pre-assessment audit be conducted several weeks or months before a Notified Body or Registrar certification audit. Our consultants will assess your system for compliance and identify areas of non-compliance and how to properly address them before your certification audit.
  3. Full or partial internal audit - ISO 13485, FDA QSR, and other regulatory requirements mandate that manufacturers conduct regular internal audits of their quality management systems. Emergo provides internal auditing services which allow for an independent review of your full quality system. We can also be contracted to conduct partial-scope audits in which we focus on specific areas of the quality system where you suspect non-compliance, or focus on areas where audits cannot be conducted by your in-house internal auditor due to possible conflicts of interest.
  4. Subcontractor or supplier audit - Critical suppliers must be "controlled." This is not only a good business practice, but often also 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. Emergo can 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. Because we maintain offices worldwide, we are able to conduct supplier audits throughout the US, Europe, Australia, Canada, Mexico, Japan and other parts of Asia   

Please contact us for more information on our medical device QMS compliance auditing services.

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