Manufacturing Electronic Medical Devices to ISO 13485 standard
Meeting the standard of your expectations
What’s more fulfilling than manufacturing PCB Assembly, Box Build and Electromechanical products that supports human health and in some cases saves lives, that’s why our staff are motivated to delivering in all areas, knowing that the products they are assembling make a difference to mankind.
Cogent Technology has been certified to manufacture electronic medical devices under ISO 13485:2003 since 2006.
Our paper-free approach means we’ve been able to integrate the processes necessary for compliance into our business systems and shop floor data collection to provide the highest standards of traceability and device history alongside tight process control for you PCB Assembly, Box Build and Electromechanical Assembly.
Our implementation of ISO 13485 allowed us to build into our workflow a number of attributes some of which go beyond just being compliant:
- Total batch traceability, to component level
- Visibility through SFDC for live progress
- Leapfrogging of process steps is prevented, electronically
- Use of non-calibrated equipment prohibited, electronically
- Operator activity, recorded and traceable to product serial number
- Integrated skills matrix restricts operators so only those certified
to build devices can handle them
- Rework and subsequent re-validation logged, in detail
- Complete electronic Device History Record (DHR)