When quality matters, Flexan delivers you peace of mind. Our quality management system across our custom contract manufacturing business units ensures that we diligently support your next custom manufacturing project through each stage of the engineering and manufacturing process. Our rigorous commitment to quality is the reason we deliver consistent levels of performance to our global customer base.
FMI Medical (A Flexan Company), offers Silicone Molding and Silicone Tubing Solutions. FMI operates a 20,000 square foot Class 7 cleanroom located at our global headquarters in Lincolnshire, IL. Certifications are based on internationally recognized management system standards developed by the International Organization for Standardization (ISO). FMI is ISO 13485 certified and FDA registered. Learn more about FMI's certifications >
MEDRON Medical (A Flexan Company), offers Thermoplastic Molding and Thermoplastic Tubing, Device Assembly, and Finishing Solutions. MEDRON operates Class 8 Cleanrooms in Salt Lake City, UT. MEDRON is ISO 13485 and ISO 14644 certified and FDA registered. Learn more about MEDRON's certifications >
Flexan's precision rubber molding division, based out of Chicago, has successfully attained the following ISO certifications. Certifications are based on internationally recognized management system standards developed by the International Organization for Standardization (ISO).
ISO 9001:2008 is the general standard which requires companies to establish, document, implement, and maintain a quality management system and continually improves its effectiveness in accordance with the requirements of the standard.
ISO 13485:2003 is the quality management system standard specific to the medical industry. The requirements emphasize critical areas impacting design, process, quality, and manufacturing reliability for medical device products.
Learn more about Flexan's Quality Assurance for Rubber Compounding and Rubber Molding.