Certified Medical Device Operations
With proven operations to support the intricate needs of growing Medical Device providers!
Operational Scale. Technical Precision.
With two decades of logistics and technical services experience, we’ve helped companies across the U.S. launch products, streamline fulfillment, and deliver smarter support. Our focus on precision, visibility, and responsiveness means we’re built to deliver at scale without sacrificing quality, setting Mendtronix apart from general logistics providers.
Our Certifications & Compliance
At Mendtronix, we hold ourselves to the highest standards of quality, safety, and regulatory compliance. These certifications demonstrate our commitment to excellence across every aspect of our operation—from medical device handling to secure data management and global logistics.
ISO 13485:2016 Certified
Quality management system for medical devices ensuring traceability, safety, and performance.
FDA Registered Facility
Officially registered with the FDA to handle and distribute regulated medical products.
HIPAA Compliant
Secure and compliant handling of protected health information (PHI).
DOT & IATA Certified
Certified for compliant shipping of sensitive and regulated materials by ground and air.
ESD‑Safe Assembly Environment
Protected areas built to prevent electrostatic discharge during sensitive electronics assembly.
Comprehensive Services
[Scalable Solutions. Built for Growth.]
SECURE WAREHOUSING
Secure storage, inventory management, pick-pack-ship, Amazon FBA prep, real-time tracking
CONTRACT ASSEMBLY
Build-to-order or build-to-stock production services including hardware assembly, device integration, and staging
KITTING & PACKAGING
Custom kitting, labeling, marketing insert prep, and deployment kits built to exact client specifications
FORWARD & REVERSE LOGISTICS
Freight and inventory movement with inspection checkpoints, real-time visibility, and scalable operations
RETURNS MANAGEMENT (RMA)
Refurbish, restock, or recycle customer returns with full traceability and audit-ready reporting
TECHNICAL SERVICES & REPAIRS
Warranty and non-warranty diagnostics, refurbishments, and functional testing performed in-house
DOMESTIC OPERATIONS
Import coordination, reshoring support, tariff-optimized operations
DOMESTIC OPERATIONS
Import coordination, reshoring support, tariff-optimized operations
Custom Solutions Start here
Our team is here to help you simplify operations, reduce friction, and find the right solution for your logistics, assembly, or fulfillment challenges.
Reach out and we’ll guide you with expert advice and tailored options — no sales pressure, just clarity.
