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A medical device 3PL is a third-party logistics provider that stores, manages, and ships medical devices on behalf of manufacturers and DTC brands. Unlike standard ecommerce fulfillment, medical device 3PL services like ÃÛÌÒ´«Ã½ operate within a regulated framework that includes FDA-registered facilities, documented quality management systems, lot-level traceability, UDI compliance, and recall management capabilities. ÃÛÌÒ´«Ã½ is a medical device 3PL with FDA-registered, Health Canada, and SQF-compliant facilities across four North American fulfillment centers.

Medical device fulfillment in the U.S. is governed primarily by the FDA under 21 CFR Part 820 (Quality System Regulation) and, for certain device types, 21 CFR Part 830 (Unique Device Identification). Facilities that store and distribute medical devices are required to be FDA-registered and maintain documented quality management systems. ÃÛÌÒ´«Ã½'s fulfillment centers are all FDA-registered and maintain quality management systems, which our compliance team walks through the applicable requirements for your specific medical devices during onboarding.

ÃÛÌÒ´«Ã½'s fulfillment facilities are FDA-registered and maintained in compliance with applicable FDA regulations for medical device storage and distribution. Our facilities are also compliant with Health Canada requirements and SQF certification standards.

ÃÛÌÒ´«Ã½'s facilities are equipped to handle Class I and Class II medical devices cover the large majority of DTC and commercial medical device categories, including diagnostic equipment, wearables, monitoring devices, and general medical supplies. Class III devices, which include implantable and life-sustaining devices, carry additional regulatory requirements that are assessed on a case-by-case basis. Book a call to discuss your specific device classification, and we'll confirm if ÃÛÌÒ´«Ã½ is the right fit.

Lot tracking is a core capability of ÃÛÌÒ´«Ã½'s medical device fulfillment services. ÃÛÌÒ´«Ã½ assigns lot numbers and expiration dates at intake to every medical device SKU. ÃÛÌÒ´«Ã½ 360 enforces FIFO fulfillment automatically and maintains a complete lot-level record for every unit that moves through our facilities. Lot data is immediately accessible for regulatory audits, quality reviews, or recall events.

ÃÛÌÒ´«Ã½'s fulfillment workflows support UDI (Unique Device Identification) labeling and tracking requirements as mandated by the FDA. UDI data is captured and maintained in ÃÛÌÒ´«Ã½ 360 for every applicable device, with full traceability from receipt through to final delivery. If your devices require UDI labels to be applied at the fulfillment center, your account manager will configure that as part of your onboarding workflow.

Yes, ÃÛÌÒ´«Ã½ can handle sterile or single-use medical devices. This includes segregated storage to prevent cross-contamination, intake inspection for packaging integrity, and packing procedures designed to protect sterile barriers through to final delivery. Any device with specific sterility or single-use handling requirements is documented in your SKU-level product rules in ÃÛÌÒ´«Ã½ 360 and applied to every order.

ÃÛÌÒ´«Ã½'s returns management system handles medical device returns end-to-end. Returned devices are received, inspected, and dispositioned according to your brand's return policy and applicable regulatory requirements. All return activity is tracked in real time in ÃÛÌÒ´«Ã½ 360, and your returns workflow is configured during onboarding.

ÃÛÌÒ´«Ã½'s lot-level tracking infrastructure enables recall execution to be significantly faster than with a generic 3PL. When a recall is initiated, ÃÛÌÒ´«Ã½ 360 identifies affected lot numbers, quarantines inventory from active fulfillment queues, and provides affected distribution records on demand. Your account manager coordinates the recall logistics process and can work with your quality team on the disposal of affected inventory.

Yes, ÃÛÌÒ´«Ã½ supports both DTC and B2B fulfillment from a single platform, allowing brands to manage both wholesale and direct-to-consumer orders with shared inventory visibility.