Not all medical device manufacturers are the same...

Cogent Technology is certified to manufacture non-invasive electronic medical devices. If your business is medical electronics, our accreditation under the mandatory ISO 13485:2003 standard for medical device manufacturing underpins the quality of any product we manufacture for you.

Achieving ISO 13485 certification requires a substantial investment to develop and adhere to processes. Our paper-free approach means we've been able to integrate these processes into our business systems and shop floor data collection - that provides you with the highest standards of traceable record keeping and gives us tight process control.

Our ongoing investment ensures we conform to the recognised industry standard, gives us total control over the manufacturing process and provides you with complete visibility and traceability. Flexibility will be important for you too, that's why we've ensured our systems can be tailored to fit the specific criteria for manufacturing your medical device.

Our investment delivers quality by:

• Giving you total batch traceability down to component level
• Making the progress of your job visible to you throughout the manufacturing process
• Following procedures that restrict movement within the process so no stage can be leapfrogged
• Identifying non-calibrated test equipment and prohibiting its use
• Tracking and recording details of operators
• Automatically referencing an operator's skills matrix to ensure we select only those individuals who are appropriately qualified to manufacture your product
• Logging any rework and subsequent re-validation
• Compiling a complete electronic Device History Record (DHR)
• Automatically emailing the DHR to you so you have your own record
• Optionally giving you remote access to the DHR through a website so you can maintain an ongoing service history

If your medical equipment manufacturer is not providing the level of service and quality you could have, contact us.