We are pleased to announce that Casco Bay Molding is now ISO 13485 certified following a three-day audit. Our growing team is committed to exceeding the safety regulations needed to produce medical applications and other challenging parts through our proven quality control processes. We were excited to demonstrate the rigor and consistency of our quality management system from product development to manufacturing to fulfillment during our ISO 13485 audit.

What Is ISO 13485?

Quality control is crucial to successful injection molding. Though ISO-certified can mean different things, it highlights that a production facility is safe, consistent and uses quality materials. Casco Bay Molding has been ISO 9001 certified for many years. We are proud of our 20-year history tackling challenging product design projects from menstrual cups to medical device valves to faucet components. In other words, our silicone and plastic injection molding facility has been in line with international quality standards for a number of years.

ISO 13485 is a subset within ISO 9001 that certifies a manufacturer for involvement at one or various stages in a medical device’s development. 

We are excited to expand our work in medical product development, machining and manufacturing in 2020. Looking for a quote for a medical product? Complete our RFQ and hear back from our team shortly.