Rochling Medical Grade ISO 13485:2003 Certified
Rochling Engineering Plastics is the only manufacturer in North America to be ISO 13485:2003 certified that supplies their broad product offering of engineering plastic stock shapes to the life science industry.

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacturing of medical devices including controls to ensure product safety; risk management activities; inspection and traceability; documentation and validation of processes and verification of the effectiveness of corrective and preventive actions.

In addition to their new ISO 13485 certification they also offer ISO 10993 compliancy, and USP Class VI compliancy or certification.

For more information, contact Birgit Karen Moecks, Rochling Engineering Plastics, 903 Gastonia Technology Parkway, Dallas, NC 28034, 704-922-7814, Fax: 704-922-7651, E-mail: info@roechling-plastics.us, Web: www.roechling-plastics.us.