When it comes to quality Medicoil’s brand is an extension of our Customers’ brands. There is no room for error and we embrace the philosophy and methods that assure the highest standards of quality. Our Quality Management System (QMS) is based on the ISO 13485 standard, to which we are certified. Processes are developed, qualified and validated using sophisticated IQ/OQ/PQ protocols.

Documented standard operating procedures (SOP’s) and quality assurance tools like APQP, control plans, failure mode and effects analysis (FMEA), process mapping and validation, and effective CAPA show Medicoil’s commitment to delivering the highest quality product to our Customers. Our quality assurance standards are about meeting Customer, regulatory, and statutory requirements using good manufacturing practices (GMP). This total quality management effort involves all members of the Company in collaboration with the Customer.

ISO 13485:2016 Certificate


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