What Does Medical Device Quality System Auditing Entail?

If you are a medical equipment manufacturer, then you certainly understand how stressful audits can be. The pressure can be exceptionally high for companies seeking FDA approval to commence mass production of a new product.

Fortunately, the thought of having to persevere through an audit need not cause unnecessary stress. With adequate preparation, you can increase your chances of getting tremendous approval. Read on to find out the three most common types of audits.

Notified Audits

If you are looking to start manufacturing new equipment, you will need a Pre-Approval Inspection by the FDA. First, you submit a proposal outlining how you intend to create the product. You also need to show that your company has the resources to manufacture the product competently. Then the FDA will visit your company to ensure that your application matches the reality of the situation. If the agents are satisfied with the condition of your site, then they will certify you to manufacture the product.

Routine Inspections

The FDA has the mandate to inspect medical manufacturing plants every two years. The Administration conducts the inspections without notification. The standards that a manufacturer must meet during routine inspections are set out in great detail in the Quality System Inspection Technique manual.

If the FDA finds any cause for concern during a routine inspection, it will schedule a further assessment to inquire further into the matter. This second inspection, called a for-cause inspection, can result in:

  • A no-action indicated verdict
  • A voluntary action indicated verdict
  • An official action indicated verdict

If you receive an official action indicated verdict, you should comply strictly with the FDA's requirements. Failure to comply could lead to the suspension or cancellation of your manufacturing certificate.

Internal Audits

Internal audits are voluntary assessments that medical device manufacturers undertake to ensure compliance with their standards. Although these audits are legally required, they are also an excellent tool for ensuring that your company has no weak quality management spots.

You should consider getting regular medical device quality system auditing services. These will help keep you on your toes and improve the overall quality of your products. Additionally, an internal audit will boost your confidence as you wait for a Pre-Approval Inspection.


Given the critical role that medical equipment plays in consumers' lives, it is hardly surprising that manufacturers have to adhere to stringent standards. The best way to ensure compliance is through audits. Now that you know the three most common types of audits, all that remains is to prepare rigorously to ensure that you excel. Keep these tips in mind when looking for medical device quality system auditing services.