Product & Educational Service LLC

Helping medical device companies get their products through the FDA approval process and into the worldwide marketplace. We are actively seeking partners to design, develop, manufacture, and distribute medical devices. Quality Systems, Design Contro...

Helping medical device companies get their products through the FDA approval process and into the worldwide marketplace. We are actively seeking partners to design, develop, manufacture, and distribute medical devices. Quality Systems, Design Controls, CAPA, Quality Assurance, Quality Control, Regulatory Affairs, 21CFR820, 21CFR211, Product fulfillment, Handling and shipping, GMP, FDA 510k Premarket Notification, FDA Premarket Approval, CE Marking, ISO 13485, ISO 14971 Risk Management