What is MEDI-FILS

MEDI-FILS is a continuous filament polyester (PET) yarn created to satisfy the requirements for medical textile implantable applications.

Certification: ISO 13485 and ISO 9001

ICF achieved both the certifications for ISO 13485:2016 and ISO 9001:2015. Our QMS system is designed to follow the needs of the Medical Implantable Device Industry. Product information and processes are available and traceable in our real time database. All the requirements of ISO 13485 are supported by a structured Quality Management System able to connect purchasing, production, sales, CAPA, external and internal resources, planning and leadership.

A database structure is used to manage data from the quote, to product specification, planning, work order, Quality Control, Certificate of Analysis and final shipping. All these steps are connected. This interaction guarantees a stable method to avoid loss of information or errors.

Traceability

Due to the organization of our database, we are able to offer full traceability from a single package of yarn, tracing back to the processes, and set-up employed to the raw material lot.

View our Certificate of Registration

FDA certified colors

ICF produces colored yarn for medical application. The technology used is know as “Solution Dyed” where the pigment is added to the polymer during the extrusion process. This guarantees uniformity, repeatability and stability of color during the final use.

Our color GREEN (D&C Green 6) and BLUE (D&C Blue 6) are batch certified by FDA. The pigment lot is tested by the FDA following the 21CFR74.3106 for the Blue and 21CFR74.1206 for the Green.

Upon request we can provide copy of the FDA certification.