Quality & Certifications

Genesis Medical Plastics is ISO 9001:2015 certified and is an FDA registered device manufacturing facility, and further certified to ISO 13485:2016.  All products are provided to our customers with certifications at no additional charge. We offer process validation including Master Validation Plans, Installation Qualifications, Operational Qualifications, and Performance Qualifications.

Our extensive quality and regulatory programs help medical device manufacturers simplify the device regulatory process with the US FDA, EU Notified Bodies and other regulatory agencies.

Genesis Medical Plastics manufactures using process monitoring and control systems. Our process equipment is designed specifically for producing the highest quality high performance polymers consistently and efficiently. Genesis Medical Plastics embraces and employs lean business practices and manufacturing techniques. We produce in single piece flow, work to eliminate waste and inefficiency, and strive for perfection in all we do and deliver. Click to read our full Quality Policy.

Scroll to Top