Mendtronix is ISO 13485:2016 Certified | FDA Registered (Iavelli Way, Poway, CA.) As such, we ensure quality at every stage through the process. Mendtronix’ Quality Management System (QMS), requires process standards that must be documented and controlled to help ensure consistent application and results. Whether in the form of Statement of Work (SOW), 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 and practices. Surrounding the documents themselves Mendtronix management implements systems of review, problem identification metrics, corrective action creation, follow-up and preventative action creation, and follow-up. Good documentation practices that prove adherence to these time-sensitive practices are critical requirements for both quality and regulatory compliance of your medical products.
Mendtronix Assembles Medical Devices
Our medical 3PL team manufacturers and fulfills medical devices on a build-to-order basis from our ISO 13485 certified facility located at 12250 Iavelli Way, Poway, CA 92064. Hardware is assembled, software loaded and systems go through rigorous quality control checks. Devices are then packed and shipped with care, not only directly to our client’s end-user (i.e. hospitals and medical clinics), but many times directly to the patient. In the unlikely event that a unit needs to be repaired or returned, our team supports reverse logistics, triage, component level repair, refurbishment and QC testing back to original specifications. It is then shipped back to the end user or made available as B stock for future needs.
Mendtronix also provides traditional 3PL services for off-the-shelf medical devices and supplies. Our team can handle omnichannel fulfillment by directly integrating our 3PL technology into your own ERP system. Clients can easily place orders from your e-commerce store or one we build for you. Orders flow seamlessly from your system to ours offering you 24/7 viewing of order status from your customized dashboard.
ISO 13485:2016 Certified Certified
Contract Assembler & 3PL Provider
Unlike other 3PL providers, Mendtronix’ ISO 13485:2016 certification (12250 Iavelli Way, Poway, CA 92064) 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 across its Atlanta, Pittsburgh, and San Diego facilities. MTI is committed to a proven quality system that link business objectives with operational efficiency. MTI demonstrates clear quality policy, effective process documentation, exceptional commitment to customers, and actionable measurement, control, and analysis.
Mendtronix is Bi-Coastal
Home therapeutics solutions demand quicker surgical or injury recoveries and 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 enable easy returns after use via low cost ground shipping. A HIPAA compliant and technically competent 3PL provider, Mendtronix is optimal since it can quickly re-purpose a returned unit for the next patient.