Medical Device ISO 13485 - 1/3/2011

Since its creation more than three decades ago, Distinctive plastics has always been very systemized. As DPI’s founder, Tim Curnutt has said, “we realized long ago that the key to accurate injection molding is consistency; everyone has to be doing the same thing over all shifts”. This led us early on to creating written procedures and traceability standards for most all we do. Due to our procedurals and traceability, our UL Listing in 1998 and ISO 9000:1994 in the year 2000 was a very easy transition. Soon after we converter our existing systems for health and safety and environmental concerns over to the ISO and OSHAS systems. We have continued to update to the new standards as they come up and in 2010 we added ISO 13485:2003; an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

 For more than 30 years DPI has provided the manufacturing industry with Technical Injection Molding Services. Just before the turn of the century, we decided to take on the very specialized practices of In-Mold Decoration and 2-Shot molding. Since that time, these specialties have grown to as much as 20% of our sales. In 2009 we decided to seek the ISO 13485 certification in order to offer not only our specialty competencies of 2-shot and IMD but also our technical Injection Molding Services including Contract Manufacturing to the Medical Device Industry.