There are many different types of Regulatory audits that can be conducted. These are audits that upon successful completion demonstrate to a regulatory body that the manufacturer is compliant with their regulations. Some audits are for one regulation while others look at multiple. The more regulations that an audit verifies for, the more complex and detailed the audit will be. These audits are done by an external auditor in order to remove bias. In some cases, regulatory actions may be taken against a manufacturer if there is a finding as a result of the audit.

One audit that is a bit simpler is the QSIT audit by the FDA. The Quality System Inspection Technique (QSIT) is a top-down style audit that is conducted by the FDA on the quality management system of medical device manufacturers. A top-down style audit is one that looks at procedures/manuals within the quality management system first and then moves downwards from there looking at forms, work instructions, and records related to the procedure viewed first. The audit is conducted to ensure compliance with the FDA’s Quality System Regulation (QSR, 21 CFR 820). Should the inspector detect a nonconformance then a Form 483 will be issued to the manufacturer. Should the inspector find no issue the manufacturer will be deemed to be in compliance with the regulations. This audit may be announced or unannounced.

Another audit that can be conducted is known as an MDSAP audit. This is the Medical Device Single Audit Program. This audit is entirely voluntary but it does allow a manufacturer to demonstrate compliance with five different regulations at once. If the audit is successful the manufacturer will be considered compliant with US FDA regulations, Australia’s regulations, Japan’s regulations, Brazil’s regulations, and Canada’s regulations. While obtaining the MDSAP certification is incredibly useful it is also incredibly difficult to obtain. The need to be compliant with all five regulations is one reason why the certification is not common. If there is a finding there is regulatory action taken against the organization, however, the organization will not gain approval to sell in those five countries.

Both these audits above, as well as other regulatory audits like a notified body audit for European union approval, are difficult to prepare for. In some cases, if it is a surprise audit there is no time to prepare at all. That is why it is better to be prepared at all times. EMMA International can help prepare a medical device manufacturer or any life sciences manufacturer for an audit. Whether it is preparing long before an audit is ever expected to occur or preparing a few days before the audit, EMMA International can set an organization up for success. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

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