Rochling Medical Grade ISO 13485:2003 Certified

摘要

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 1 3485 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.