Rochling Engineering Plastics is ISO 13485:2003 Certified

As one of the leading plastics manufacturers worldwide, featuring the most comprehensive product line of engineering plastics within the U.S. and Canada, Röchling strives to continuously improve its offerings and services and hereby announces to be ISO 13485:2003 certified.

Röchling Engineering Plastics provides a complete line of Medical Grade plastics for medical devices, medical instrumentation and orthopedic trials such as: surgical instruments and devices, orthopedic sizing trials, imaging and monitoring, surgical trays, diagnostic equipment, dental equipment and devices, pharmaceutical manufacturing and biotechnology. Featured products are SustaPEEK MG, Sustason PPSU MG (Radel® R), SustaPEI MG (Ultem®), Sustarin® C MG (Acetal) and Polystone® P MG (Polypropylene).

The materials are available as sheets and rods and Röchling is able to provide in addition to its new ISO 13485 certification, ISO 10993 compliancy, ASTM, USP Class VI & FDA compliancy (as applicable), lot & batch traceability and ultrasonic testing.

Source: Rochling Engineering Plastics

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