Cannon Quality Group, LLC

Our purpose at Cannon Quality Group is to be the CHANGE in Quality!

Since 2010, we have been providing Quality Management Systems solutions to medical device, diagnostic and IVD companies. Our number one priority is delivering QMS solutions that make sense for the stage and goals of your business. CQG implements this focus by following two core beliefs: We don’t believe in fear-based Quality Management. We don’t believe in a one-size-fits-all Quality Management System.

Helping you attain and maintain medical device quality system compliance with FDA, Sherman Act / CAL FDB, MDD (Medical Device Directive), the new MDR (Medical Device Regulation), ISO 13485, ISO 14971, IEC 60601, IEC 62366 and/or IEC 62304 is our area of expertise.

Our Quality Management Services include:
*Implementing and Maintaining Quality systems and departments to comply with numerous international regulations/guidances/programs. Examples include: FDA CFRs, MDD, MDR, ISO 13485, CMDR, Japan, TGA.
*Supplier audits and compliance
*Internal audits
*Quality projects
*Controlled environment room (CER) support
*Founders Club memberships. Gain access to our shared space facility equipped and ready for testing Including an ISO Class 7–certified Controlled Environment Room (CER)
FDB certification/audits
*First in human. Investigational Device Exemption (IDE) approval
*FDA audits/FDA clearance/QSR compliance
*MDSAP Audits
*Notified Body Audits/Technical File and Design Dossier Support
*Complete Quality Department outsourcing

Please visit us at www.cannonqualitygroup.com or email us at [email protected] for more information.

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