Mendtronix Inc. (MTI) is ISO 13485:2016 Certified | FDA Registered (12250 Iavelli Way, Poway, CA.) MTI ensures quality throughout the product lifecycle. MTI’s Quality Management System requires process standards that are documented and controlled to ensure consistent application and results. Whether in the form of Quality Procedures, Standard Operating Procedures (SOP), or Work Instructions, MTI’s rigorous processes are maintained and audited to ensure compliance with best practices.
Medical Devices Assembly
MTI assembles complex medical devices on a build-to-order basis, and fulfills customer orders from our ISO 13485:2016 certified and FDA registered facility located at 12250 Iavelli Way, Poway, CA. Hardware is assembled, software loaded, and units subjected to rigorous quality control checks. Devices are then packed and shipped with care, either directly to our client’s end-users (i.e. hospitals and medical clinics), or directly to the end-user patients. In the event that a unit needs to be repaired or returned, MTI supports reverse logistics, triage, component level repairs, refurbishment, and QC testing, to return medical devices to their original specifications.
ISO 13485:2016 Certified Contract Assembler & 3PL Provider
Mendtronix provides forward logistics support for medical devices under its ISO 9001 QMS on a bi-costal basis. We also provide product return, physical inventory, and quarantine support/disposition. (12250 Iavelli Way, Poway, CA.)
Mendtronix is Bi-Coastal
Mendtronix quickly fulfills device orders, helping mitigate costs to patients and insurance companies. MTI can ship medical equipment same day with 1-2 day delivery, and also enables easy returns after use via low cost ground shipping.