Quality Philosophy & Committment

At Primo Medical Group we realize quality is of the utmost importance to our customers. Primo Medical Group maintains a quality system that meets or exceeds current Good Manufacturing Practices (cGMP) and our customers' high standards. Primo Medical Group's quality system was developed in compliance with the FDA's Medical Device Quality System Regulation 21CFR820.

Our quality system is focused on Continual Improvement and complete compliance with both regulatory and customer requirements. The Company's mission is to provide products and services that meet or exceed customer expectations while complying with applicable specifications and regulations.

Company Quality Policy

"Customer Satisfaction through Conformance to Standards, Continuous Improvement and Commitment to an Effective Quality Management System"

Trust the Quality Experts at Primo Medical Group for Proven Regulatory Compliance

Primo Medical Group’s ISO 13485:2016-certified quality systems and FDA-compliant processes ensure every product meets the highest standards of safety, consistency, and performance. With decades of experience supporting medical device manufacturing and regulatory compliance, our team is committed to continual improvement and full adherence to customer and industry requirements. Contact us to learn more about our quality assurance programs or request a quote to discuss your next project.