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Datalink Electronics

01509 231023

Medical Devices

Medical Devices

Datalink Electronics have combined their knowledge of regulatory requirements with a vast range of expertise in electronic product development, in orded to provide you with a medical product fully certified and fit for market. Our key services in this sector are:

Compliance with standards and regulations: Medical Devices Directive Risk management (ISO14971) IEC 60601 family of standards Product specific standards Software life-cycle processes (BS EN 62304) Design to the requirements of ISO13485 Electronic product development Full verification and validation Production of the Technical File Liaising with the notified body of your choice during the approval process Multi-disciplinary product development Commercialisation of the state-of-the-art technologies

For more information on  Medical Devices  talk to  Datalink Electronics

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