Mendtronix is ISO 13485:2016 Certified | FDA Registered (12250 Iavelli Way, Poway, CA.) As such, Mendtronix is capable of ensuring quality throughout the product lifecycle process. Mendtronix’ Quality Management System (QMS), requires process standards that are documented and controlled to help ensure consistent application and results. Whether in the form of Quality Procedures (QP), Standard Operating Procedures (SOP), or Work Instructions (WI), Mendtronix’ process documents are maintained and audited to ensure compliance with practices that, in turn, drive consistent, reliable, and safe products. Surrounding the documents themselves, Mendtronix management implements systems of review, problem identification metrics, corrective action, preventative action, and follow-up.
Mendtronix Assembles Medical Devices
Mendtronix assembles and fulfills medical devices on a build-to-order basis from our ISO 13485:2016 certified and FDA registered facility located at 12250 Iavelli Way, Poway, CA. Hardware is assembled, software loaded and systems go through rigorous quality control checks. Devices are then packed and shipped with care, either directly to our client’s end-user (i.e. hospitals and medical clinics), or directly to the end-user patient. In the event that a unit needs to be repaired or returned, our team supports reverse logistics, triage, component level repair, refurbishment and QC testing to return the medical device to its original specifications.
Mendtronix also provides traditional 3PL services for off-the-shelf medical devices and supplies. Mendtronix can handle omnichannel fulfillment by directly integrating our 3PL technology with a client’s ERP system. Clients can easily place orders from their e-commerce store or one MTI build on their behalf. Orders flow seamlessly between MTI’s and our clients’ systems, offering 24/7 viewing of order status from a customized dashboard.
ISO 13485:2016 Certified
Contract Assembler & 3PL Provider
Unlike other 3PL providers, Mendtronix’ ISO 13485:2016 certification (12250 Iavelli Way, Poway, CA) demonstrates the rigor of its policies and procedures related to the manufacture, assembly, documentation, servicing, and risk mitigation of medical devices. Mendtronix is also an ISO 9001:2015 approved logistics partner, with quality management systems in place at its Atlanta, Pittsburgh, and San Diego facilities. MTI is committed to maintaining a quality system that links business objectives with operational efficiency. MTI demonstrates a clear quality policy, effective process documentation, exceptional commitment to customers, actionable measurement, control, and analysis.
Mendtronix is Bi-Coastal
Home therapeutics solutions demand quicker surgical or injury recoveries to help avoid or shorten hospital stays. Mendtronix quickly fulfills medical device orders, helping mitigate costs to patients and insurance companies. Mendtronix can ship medical equipment same day with 1-2 day delivery, and also enables easy returns after use via low cost ground shipping.