As engineers at heart, Cogent Technology took a structured approach to meeting ISO13485 requirements. We worked closely with our business systems providers to ensure compliance was built into our workflow.

Our MRP system goes beyond generating work orders. It defines routing, collects shop floor data, and builds a complete medical device history record. This process verifies component use, operator suitability, and test results, all under strict control. As a result, every step follows a structured sequence, maintaining full traceability from sub-assemblies to finished medical devices.

Additionally, our MaPS system integrates with our QMS, handling change control, concession authority, and capacity planning while tracking key performance indicators (KPIs). This allows us to ensure high-quality manufacturing and provide clients with complete confidence.

Since these systems are critical to our operations, they undergo strict verification and validation—just like any hardware or software process. Our validation methods follow FDA Process Validation Guidance and SG3’s Quality Management Systems – Process Validation Guidance, both endorsed by the Global Harmonization Task Force.

This commitment to rigorous compliance, traceability, and process validation ensures we deliver medical devices of the highest quality while maintaining full regulatory adherence.

At Cogent Technology, we are driven by a passion for creating medical devices that improve human life. We understand that good things take time, especially in the medical device sector.

The early stages of development and New Product Introduction (NPI) in this field are often more complex and time-consuming than in conventional industries. Clinical trials can be lengthy, often requiring multiple iterations before volume production begins. While you are well aware of this, we want you to know that we fully appreciate the process and are committed to supporting you throughout the entire journey. We are in it for the long term.