FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

• Who must comply with FDA QSR?
• What is the FDA’s audit procedure for QSR compliance?
• Does our existing QMS comply with 21 CFR Part 820?

Meeting 21 CFR Part 820 compliance

The US Food and Drug Administration (FDA) requires medical device manufacturers to implement a quality system that meets the Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820. The QSR is similar to the ISO 13485 standard for quality management systems, but not the same.

Who needs to comply with the FDA QSR?

If your company manufactures a medical device or in vitro diagnostic (IVD), you are probably required to implement a quality management system that is compliant with 21 CFR Part 820. If you are responsible for the design and post-market activities of the device, the US FDA considers you a "manufacturer" even if you outsource all of your manufacturing activities. Therefore, most companies marketing a medical device or IVD must implement a QSR-compliant system.

How the FDA enforces compliance with QSR

Most countries require proof of compliance with their quality system requirements BEFORE you place a device on the market. The FDA, however, does not require a pre-registration audit for Class I and II device manufacturers. Instead, the FDA conducts pre-announced inspections to check compliance; the FDA can also perform random, unannounced inspections.

Even though the FDA will not require a pre-registration audit, you are required by law to be in compliance with applicable sections of the QSR before placing your device on the market. If the FDA visits your facility for an inspection and finds the facility not in compliance, they may issue a Form 483. You must conduct internal audits of your quality management system to support compliance claims.

Why choose Emergo for your 21 CFR Part 820 compliance projects?

As an experienced medical device regulatory consulting firm, Emergo has implemented hundreds of 21 CFR Part 820 and ISO 13485 compliant quality management systems for medical device and IVD manufacturers in North America, Europe, and Asia. Here’s how we can help:

• We customize your FDA medical device quality management system to meet your business needs. They are not "off the shelf" solutions or based on package software. Our quality management systems are fully compliant with the FDA QSR.
• We specialize in helping small- to medium-size companies implement 21 CFR Part 820. Our consulting and project management teams work together to deliver your quality management system on time and within budget.
• We can tailor your quality management system to meet the full compliance requirements of ISO 13485, Canadian Medical Devices Regulations, Brazilian GMP, and Japanese Ordinance #169.
• We are always accessible and provide support during your project, on-site and off-site.
• On-site training for your key employees is included in our FDA QSR consulting fees.

Contact us for more information about FDA QSR consulting support and implementation for compliance with 21 CFR Part 820.

Common FDA QSR and 21 CFR 820 compliance questions

Are Class II and Class I devices exempt from QMS requirements?

No. It is important to note that Class II devices and most Class I devices are not exempt from QSR (current Good Manufacturing Practice) requirements.

My company already has ISO 13485 - is that sufficient?

The FDA does not recognize ISO 13485 as compliant with FDA QSR (21 CFR Part 820). However, if you already have ISO certification, we can assist you in integrating FDA quality system requirements into your existing quality management system.

How long does it take to implement FDA QSR - 21 CFR Part 820

The amount of time needed to comply with 21 CFR Part 820 varies depending on the number of facilities, complexity of your manufacturing process, level of management support, and whether someone in the company is fully dedicated to quality management. Our experience shows most medical device and IVD manufacturers can implement a QSR-compliant quality management system in three to seven months.

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