Quality and Regulatory

Our mission is to enable low-cost, portable, 3D X-ray devices that improve the diagnosis of patients. To do this, we are developing products in accordance with ISO 13485:2016, driven by a risk focussed approach based on ISO 14971:2012.

 

We will comply with the relevant sections of IEC-60601-1 for our hardware; IEC 62304 for our software. 

 

Our aim is to grow and evolve our Quality Management System to support potential customer market location requirements, including the United States (FDA), Europe (MDR 2017/745), Japan, China and South Korea.

 

Adaptix Limited implements and maintains an effective Quality Management System designed to enable the delivery of innovative low dose digital tomosynthesis Flat Panel X-ray medical devices and related services.  We aim to ensure that we consistently exceed customer expectations and to address customer satisfaction through the effective setting of company objectives including continual improvement and the prevention of nonconformity.

 

The Company's directors and all staff are committed to complying with the regulatory and safety requirements applicable to medical devices and related services and to ensure the continual effectiveness of our Quality Management System.

© 2019 by Adaptix Limited  |  Registered in England & Wales no. 06857417 | VAT No. 119317422

For Terms and Conditions please see Terms and Conditions

At Adaptix we support and comply with the General Data Protection Regulation (GDPR).  

Further information about our Data Protection Policy is available here.

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Disclaimer:

Adaptix 's Flat Panel X-ray sources and associated software are components intended to be integrated into products by X-ray systems manufacturers. Systems manufacturers are responsible for qualifying and validating their products for intended uses and meeting all applicable regulatory requirements.