ISO 13485 Certified Medical Grade Logistics
Since 2018, we have delivered compliant medical device logistics built on the ISO 13485:2016 standard. Our focus on precision, quality, and reliability ensures your products move through the supply chain with total confidence.
Medical Logistics Excellence
Maintaining ISO 13485:2016 certification means every process we follow is documented, traceable, and regularly audited. This proven system ensures consistent accuracy, dependable performance, and confidence for every client we serve.
Medical Logistics Excellence
ISO 13485 logistics ensures consistent quality, traceability, and compliance across medical device handling. Our documented and measurable processes deliver reliable, accurate performance for regulated products.
Documented SOPs
Every process is standardized, verified, and audit-ready for consistent performance.
Risk Management
We identify and address potential issues early to keep your supply chain protected.
Preventative Actions
We identify root causes, correct issues, and implement preventive actions to maintain consistent, reliable operations.
Traceability:
Full lot and serial tracking from receiving to shipping ensures total visibility.
Validation
All systems and workflows are validated to maintain reliability.
Continuous Improvement
We go beyond compliance with ongoing audits and improvements that drive operational excellence.
Why It Matters Beyond Medical
Our ISO 13485:2016 certification doesn’t just benefit medical clients. The same precision and discipline strengthen every part of our logistics operation, improving performance for all industries we serve. Our ISO 13485 logistics capabilities ensure every shipment maintains full compliance from storage through final delivery.
Inventory Accuracy
Reduced errors, higher confidence.
Accurate inventory control is a critical component of ISO 13485 logistics, ensuring regulated products remain traceable at every stage.
On-Time Fulfillment
Consistency you can count on.
Proven processes and documented controls ensure your orders are fulfilled accurately and on schedule, every time.
Order Defect Rate
Quality that shows in every shipment.
Validation and risk management result in fewer mistakes and greater customer satisfaction.
Compliance & Security
safeguards, trained teams, and secure data management.
ISO 13485:2016 Certified
Full compliance with medical device quality management system requirements, supporting consistent and reliable operations.
HIPAA Ready
Secure handling of sensitive healthcare data with controlled processes designed to support regulatory and client expectations.
Data Management
Robust safeguards and controlled access to protect sensitive information.
Reliable Processes
with workflows aligned to ISO 13485 logistics standards.
Receiving → QC
Products are checked and verified carefully upon arrival.
Storage → Lot/Serial Control
Items are stored under controlled conditions securely and accurately.
Pick/Pack → Scanning
Orders are carefully prepared, scanned, and verified before shipping.
Shipping
Safe and accurate delivery of orders to your customers.
Reverse Logistics Support
Efficient handling of product returns and related post-shipment processes.
Use Cases & Industries Served
industries and applications.
Medical Devices / IVD Kits
Ensuring precise handling, storage, and delivery of sensitive medical products.
Clinical Trial Materials
Reliable logistics for clinical studies and research materials across sites.
Consumer Health
Safe storage and distribution of vitamins, supplements, and health goods.
High-Value Electronics
Secure handling and delivery of electronics requiring strict quality controls.
Certifications & Compliance
Mendtronix upholds the highest standards of quality, safety, and compliance. Our certifications reflect a commitment to precision, reliability, and trust, ensuring every product and service meets strict industry requirements.
ISO 13485:2016 Certified
Quality management system for medical devices ensuring traceability, reliability, and consistent performance under strict standards.
FDA Registered Facility
Officially registered with the FDA to handle, store, and distribute regulated medical products in full compliance with federal requirements.
HIPAA Compliant
Secure and compliant management of protected health information (PHI) with safeguards that ensure privacy, integrity, and confidentiality.
DOT & IATA
Managed by DOT and IATA certified material handlers to ensure compliant shipping of sensitive and regulated materials.
ESD‑Safe Assembly
Controlled environments designed to prevent electrostatic discharge and protect sensitive electronic components during assembly.
Frequently Asked Questions
What does ISO 13485 cover?
ISO 13485 defines requirements for a quality management system used in medical device handling, including documentation control, storage, traceability, risk management practices, and compliant operational workflows.
How is ISO 13485 different from ISO 9001?
ISO 9001 is a general quality standard, while ISO 13485 is specialized for medical devices and requires higher levels of documentation, traceability, and process control.
Can non-medical clients benefit?
Yes. Many non-medical companies benefit from ISO 13485-level controls to improve accuracy, traceability, documentation, and overall operational reliability.
Do you handle lot/batch and chain of custody?
Yes. Mendtronix supports full lot tracking, batch control, serialized inventory, and documented chain of custody throughout the logistics workflow.
Can you support UDI (Unique Device Identification) tracking?
Yes. Mendtronix supports UDI labeling, scanning, and traceability to ensure products remain compliant with medical device tracking requirements.
Can you support temperature-controlled shipments?
We provide temperature and humidity monitoring for stored products; however, our facilities do not offer active temperature-controlled environments.
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