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FDA QSR Audits for Medical Device and IVD Companies

The US Food and Drug Administration requires manufacturers to implement a quality management system in accordance with the Quality System Regulation per 21 CFR Part 820, also known as current Good Manufacturing Practice.

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  • What are the FDA’s internal audit requirements under 21 CFR Part 820?
  • Which areas of your quality management system should be covered by an internal audit?
  • How can pre-inspection and mock audits prepare you for real FDA inspections?

The US Food and Drug Administration (FDA) requires manufacturers to implement a quality management system in accordance with the Quality System Regulation (QSR) per 21 CFR Part 820, also known as current Good Manufacturing Practice (cGMP). Manufacturers, specification developers, contract manufacturers, re-labelers/re-processors, and even some distributors must implement a quality management system compliant with the QSR.

Medical device and IVD manufacturers must also conduct internal audits of their quality management system in accordance with the QSR. Failure to conduct internal audits can result in product quality issues, lack of process improvements, or regulatory compliance issues. Emergo can perform independent internal audits on behalf of clients to determine quality system compliance, particularly for clients lacking the resources or experience to perform their own audits.

FDA QSR 21 CFR Part 820 compliance audit services

  • Gap analysis audit – Through this audit we will assess your current level of compliance with FDA regulation 21 CFR Part 820. The gap analysis can be conducted at any time on the quality management system to identify deficient areas.
  • Full or partial internal QSR audit – FDA regulations require manufacturers to conduct regular internal audits of their quality management system. Emergo provides internal auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on particular areas of your quality management system where you suspect non-compliance occurs or has occurred, or focus on areas where conflicts of interest make an external, independent audit desirable.
  • Supplier audit - As part of your full or partial QMS audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operation. We can conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.
  • FDA pre-inspection audit – We can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. Emergo can assist you in identifying problem areas in your quality management system prior to an FDA inspection. This pre-inspection audit is similar to a gap audit, but we focus on areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, design controls, corrective and preventive action, manufacturing processes, special processes.
  • FDA QSR mock audit – We can also perform a QSR audit that would mimic an FDA inspection to help you prepare for an actual FDA inspection. This type of audit can be provided as independent assessment of readiness without company personnel being aware. FDA QSR mock audits are performed using the FDA's Quality System Inspection Technique (QSIT) in preparation for an actual FDA inspection.

FDA QMS inspection support with Emergo by UL and Greenlight Guru

Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.

Looking for Greenlight Guru eQMS information?

FAQs - QSR audit and inspection requirements for medical devices

Do I have to implement a quality management system for a Class I device?
It depends on the requirements of the FDA classification regulation/product code assigned to the device.

Is ISO 13485 sufficient?
No. The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR part 820). Furthermore, ISO 13485 certification is not equivalent to FDA QSR compliance.

When will FDA inspect me?
Manufacturers of Class II and III medical devices are to be inspected by the FDA every two years. The FDA can inspect you at any time with little notice. The FDA prioritizes inspections by risk with greater priority given to higher risk devices and situations.  If you manufacture devices that are implantable, life supporting or life sustaining, you are more likely to be inspected.

What happens if I get inspected and it does not go well?
If the FDA inspects you, and they find deficiencies with your quality management system, they may issue a Form 483 Notice of Inspectional Observations. You will have a specific period of time to address the issues noted by the FDA Investigator.

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.


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