Cannon Quality Group, LLC

Cannon Quality Group, founded in 2010, provides Quality Management Systems (QMS) solutions for medical device, Medtech, IVD, pharmaceutical, and SaMD companies. The firm has supported over 200 organizations across various stages of product development, offering services ranging from initial quality system setup to fully outsourced quality departments.

The company specializes in implementing risk-based, right-sized QMS solutions that align with regulatory requirements including FDA QSR and ISO 13485:2016 certification. Core capabilities include internal and supplier audits, document control, validations, gap analyses, and medical writing services. CQG has pioneered a consolidated supplier audit program that allows multiple clients to share audit costs and results.

The firm employs 25 quality professionals and reports that 88% of past clients remain in business, with 30% having been acquired or gone public. CQG's approach emphasizes practical quality systems that support innovation rather than create bureaucratic obstacles.

Consider Cannon Quality Group if you're a medical device company seeking practical, stage-appropriate quality systems rather than overly complex compliance frameworks. Their founder's background as a frustrated engineer turned quality professional informs their philosophy of creating useful systems that enable rather than hinder innovation.

The consolidated supplier audit program offers particular value for startups and small companies who need audit reports but lack resources to conduct their own comprehensive supplier assessments. Expect a collaborative approach focused on preparing your organization for regulatory success while maintaining operational efficiency.

Cannon Quality Group serves exclusively within the medical device, in vitro diagnostic (IVD), pharmaceutical, and Software as a Medical Device (SaMD) sectors. Their expertise centers on regulatory compliance for medical products including FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016 standards. The firm provides specialized support for First in Human studies, Food & Drug Branch certification, and medical writing for regulatory submissions including CE marking documentation.

Medical device and IVD companies at startup to mid-stage seeking FDA clearance, ISO 13485 certification, or CE marking. Organizations that value practical quality systems aligned with business objectives over rigid compliance frameworks. Companies needing external quality expertise without hiring full-time quality staff, or those looking to streamline overly burdensome existing systems.