FDA QSR Compliance
Cannon Quality Group Offers Audits & Training to Ensure Your Device is Ready for FDA Approval or Clearance
At Cannon Quality Group, we take a simple, risk-based approach to QSR compliance and FDA clearance. Whether your startup MedTech company requires support for an audit or you wish to tighten your company’s QMS to stand up to the scrutiny of the FDA, you can count on Cannon Quality Group.
Contact Cannon Quality Group today if your product needs help becoming FDA- or QSR- compliant.
Who Needs FDA Clearance & Approval?
The Food and Drug Administration regulates all medical devices marketed in the United States. As such, it’s imperative that your processes and procedures conform to FDA’s quality system regulation guidelines. The FDA has also announced its intention to use ISO 13485 as the basis for its quality system legislation.
The exact quality requirements for medical devices are listed in Title 21, Part 820 of the U.S. Code of Federal Regulations. This document depicts the responsibilities of medical device providers in regards to packaging, labeling, storage, and other components of the product.
To ensure your medical device is up to the FDA’s standards as well as ISO 13485:2016, contact the quality management professionals at Cannon Quality Group today!
Our FDA QSR Compliance Services
Our founder created Cannon Quality Group after spending years in MedTech engineering. Our quality management company was born to help medical device companies create simple, risk-based QMS solutions that give quality managers an easy, useful, and efficient tool instead of forcing them to rely on a fear-based strategy.
To accomplish this, we’ve developed a multitude of strategies and services that help companies succeed and become compliant with different standards, including those set by the Food and Drug Administration and the ISO 13485 standard. These include:
- FDA mock audits – Using the same standards set by the FDA, our experienced auditors can evaluate your product procedures and determine what areas of your quality management system need to be updated or modified
- Gap analyses – As standards evolve over time, many clients ask us to perform a gap analysis, where we determine where they are today, where they need to be or will soon need to be, and the steps to close the gap.
Although the requirements laid out in Title 21, Part 820 of the U.S. Code of Federal Regulations may be somewhat cryptic and difficult to implement at first, the team at Cannon Quality Group has the experience and knowledge to help your product develop quality management systems that fulfill each QSR quality subsystem, including management controls, design controls, corrective and preventive actions, and product and process controls.
The quality system regulation maintenance experts at Cannon Quality Group can help ensure you meet the QSR compliance requirements necessary to meet the expectations of the FDA. Contact us online to let us know how we can help on your device’s QSR compliance journey.
Choose Cannon Quality Group for Medical Device QSR Compliance Services
Though based in California, our quality team is able to provide FDA QSR services for startup medical device companies all over the United States.
If you’re concerned or confused about the FDA clearance approval process for medical devices, entrust the quality management solutions team at Cannon Quality Group to shed some light on the subject and get your product to market — fast.
Contact Cannon Quality Group for more details regarding our services. Also, be sure to learn about our Founders Club memberships, which give companies access to a controlled environment room, tools, lab equipment, and more.