Medical-Grade Logistics, ISO 13485 Certified
Since 2018, we have upheld the highest medical device quality standard, ISO 13485:2016, delivering precision, compliance, and reliability that few logistics providers can equal.
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
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.
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.
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.
Inventory Accuracy
Reduced errors, higher confidence.
Every item is tracked with precision, giving you real-time visibility and dependable stock accuracy.
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 You Can Trust
We maintain strict adherence to ISO 13485 standards and relevant regulations. Our workflows include access controls, employee training, 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.
Processes You Can Trust
Our proven processes ensure every product is handled with accuracy, care, and compliance. From receipt to delivery, we maintain full traceability and reliability at every step.
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
Our ISO 13485-certified processes serve a wide range of 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 for medical devices, including traceability, CAPA, and audit readiness.
How is this different from ISO 9001?
ISO 13485 is specific to medical devices, emphasizing regulatory compliance and patient safety, whereas ISO 9001 is a general quality management standard.
Can non-medical clients benefit?
Yes, our rigorous processes improve accuracy, traceability, and reliability for any industry, not just medical.
Do you handle lot/batch and chain of custody?
Absolutely. Every product is tracked from receiving to shipping to maintain full chain-of-custody.
Can you support UDI (Unique Device Identification) tracking?
Yes. We support processes for managing and tracking Unique Device Identification (UDI) as required for regulated medical devices.
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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