Quality
Quality you can trust
A Commitment to regulatory compliance.
ICS Medical Devices invests in advanced tools, processes, and expertise. At ICS we have a strict Quality Management System (QMS) in place to cover all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, packaging and more.se to deliver world-class catheter solutions.
Find below our Certificate of Registration for our Quality Management System, certified to ISO 13485:2016 for medical-device manufacturing at ICS Medical Devices.
This certification reflects our commitment to regulatory compliance, robust quality processes, and the consistent delivery of safe, reliable, and high-performance medical-device solutions.
certified excellence
Certified Excellence
ISO 13485 Certified QMS
Our QMS is ISO 13485 certified for design and development activity through to full-scale manufacturing, ensuring compliance to the highest international standards for medical devices, demonstrating dedication to delivering reliable, safe, and effective products to our customers.
Comprehensive Quality Capabilities
Quality Support
At ICS Medical Devices, our quality team brings extensive expertise to ensure safe and effective product, manufactured to the highest standards.
Quality Services Include:
- Production control and traceability through all phases of the product lifecycle.
- ISO Class 8 / Class 100,000 Cleanroom: with strict environmental and microbiological controls.
- Finished device packaging & labeling controls.
- Equipment, process and test method validations.
- Development: Supporting Design Verification, Design Validation, Biocompatibility and Sterilisation activity.
- Risk Management expertise applied throughout the product lifecycle.
