The US Food and Drug Administration requires manufacturers, specification developers, contract manufacturers, and relabelers/reprocessors 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 QSR?
If your company manufactures a medical device or IVD, you will generally be required to implement a quality management system that is compliant with 21 CFR Part 820. The FDA defines “manufacturer” as “any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."
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 can 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 ensure compliance; however, they can 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 the applicable sections of the QSR before placing your device on the market. If the FDA visits your facility for an inspection and they find you are not in compliance, they may issue a Form 483. You must conduct internal audits of your quality management system to ensure it is in compliance.
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 (QMS) for medical device and IVD manufacturers in North America, Europe and Asia.
Here’s how we can help:
- We customize your FDA QSR medical device quality management systems 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 Quality System Regulation.
- 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 QMS on time and within budget.
- If desired, we can tailor your quality management system to also meet the full compliance requirements of ISO 13485, Canadian Medical Devices Regulations, Brazilian GMP, and Japanese Ordinance #169.
- We are always accessible to you 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 on FDA QSR consulting support and implementation for compliance with 21 CFR Part 820.