Quality and Regulations

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 starting up six years ago, with its commitment to delivering safe, effective, reliable and clinically accurate devices to the medical health sector. It is a great example of how, when appropriately implemented, regulations can ensure public health benefit and the safety of the patients, health care workers and the community, whilst at the same time allowing new technology to be created which will not only save time and money within the NHS and other health care organisations but will, ultimately, save lives.

Impacting everything from patient safety to customer satisfaction, quality was the catalyst for organisational action since its corporation, including the appointment of Julian Jones, our Chief Compliance Officer.

Isansys Lifecare Ltd is committed to the highest level of quality in the design, development, production, refurbishment, sales and distribution of medical devices.

Download: EC Certificate - Full Quality Assurance System

Download: Quality Management System - ISO 13485:2003 & EN ISO 13485:2012

Our Quality Policy

To provide safe and effective medical devices that meet customer needs.

To maintain compliance with applicable customer, statutory, regulatory and quality system requirements.

To maintain the effectiveness of the quality management system.

Isansys Management System is certified as being in conformity with ISO 13485 – Medical devices. Quality management systems. Requirements for regulatory purposes.