Quality and Regulations

Quality and regulatory compliance built in

Quality is a key driver of success for Isansys and the clinicians and patients who benefit from our Patient Status Engine.

Isansys has taken a strong stand since it was established with its commitment to delivering safe, effective, reliable and clinically accurate devices to the medical health sector.

The Patient Status Engine is a Class IIa CE-marked and Class II 510(k) cleared medical device. It is designed, manufactured and delivered knowing that patients, their clinicians and their families are counting on quality. From material sourcing and selection, through to product testing and monitoring, Isansys is committed to delivering safe, effective, reliable and clinically accurate devices to the medical health sector.

All our devices and systems are approved medical devices, ready for clinical use. We work to an accredited ISO13485: 2016 quality management system and develop advanced products with quality and regulatory compliance designed in from the outset.

 

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