Health Care & Medical Devices

Health care (source the Health Foundation)

No universally accepted definition of quality exists within healthcare but the majority of health care systems around the world make a commitment to the people using and funding their services to monitor and continuously improve the quality of care they provide. In England, the NHS organises itself around a single definition of quality’

"Care that is effective, safe and provides as positive an experience as possible by being caring, responsive and person-centred".

This definition also states that care should also be well-led, sustainable and equitable, achieved through providers and commissioners working together and in partnership with, and for, local people and communities. Health care systems across the UK are also considering the environmental impacts of the services they provide as part of their efforts to improve care quality.

Health and social care services using ProActive system design will always be consistent with both ISO 9001 and CQC requirements for health and adult social care sectors.

Medical Devices ISO 13485

Medical device quality management systems provide a structured system of procedures and processes covering design, manufacturing, supplier management, clinical data, risk management, complaints, storage, distribution and product labelling.

Medical devices differ in their the classification. Companies producing medium-risk (Class II) or high-risk devices (Class III) devices apply a different QMS to companies making low-risk, non-sterile, non-measuring, non-reusable surgical instrument devices (Class I). 

ISO 13485 medical device quality systems using ProActive are today demonstrating the ability of our client users to provide safe medical devices that consistently meet customer and regulatory requirements. 

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