FDA Registration & Compliance

We are compliant with FDA Quality Systems Regulations and are a FDA Registered Contract Manufacturer.

75 Mill Street  •  Stoughton, MA 02072

Registration #1222928

375 West Street  •  West Bridgewater, MA 02379

343 Manley Street  •  West Bridgewater, MA 02379

Registration #3009420598

Owner/Operator #9004401).

Trust the Quality Experts at Primo Medical Group for FDA-Compliant Manufacturing

As an FDA-registered contract manufacturer, Primo Medical Group upholds the highest standards of product safety, documentation, and regulatory compliance. Our ISO 13485:2016-certified quality systems ensure every device and component meets FDA requirements for design, process control, and validation. Contact us to learn more about our FDA-compliant manufacturing capabilities or request a quote to begin your next project.