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
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: firstname.lastname@example.org, Web: www.roechling-plastics.us.