Medical Device Manufacturing and Plastic Injection Molding
Diversified Plastics is uniquely qualified to offer high-precision medical device manufacturing, plastic injection molding and clean room assembly. Our ISO Class 8 clean room (Class 100,000) has a positive airflow and is climate controlled to produce precise medical components. Sonic welding, assembly and medical packaging are just a few of the value-added services we offer.
Diversified Plastics has been ISO 9002 certified since 1994 and added ISO 13485 medical standards registration in November 2009. Our quality department is familiar with FDA 21 and CFR 820 specifications. Our procedures include IQ, OQ, PQs and other validation requirements. Strict lot traceability is adhered to at all times.
Diversified Plastics also has extensive experience with the following:
- PEEK, Ultem, polypropylene, polycarbonate and many other medical grade resins
- FDA-approved dyes
- Insert molding and overmolding of thermoplastic elastomers
Diversified Products capabilities in medical molding and medical device manufacturing continues to expand. Our design assistance and mold making experience along with clean room assembly make us a single-source supplier. Diversified Plastics is delighted to work with you on the design and manufacturing of your medical device.