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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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