About Us

ShineHealth Ltd is a specialist company providing support to Health IT suppliers implementing clinical software, to assure the clinical safety of their healthcare IT solutions. In England, this includes activities to meet the mandatory requirements DCB 0129: Clinical Risk Management: It’s Application in the Manufacture of Health IT Systems and DCB 0160: Clinical Risk Management: It’s Application in the Deployment and Use of Health IT Systems. For Software as a Medical Device (SaMD), including AI applications, support is provided to comply with ISO 14971: Application of Risk Management to Medical Devices. 

The company was founded in 2018 by Dr Jenny Dean who, in addition to a decade as a doctor in the NHS, has years of experience in executive clinical leadership roles in the Health IT industry. She understands first hand the challenges, but also the benefits and value, of implementing a clinical risk management approach to Health IT solutions and implementation.

We can help with a range of tailored solutions to Health IT suppliers and NHS organisations based on your unique circumstances, whether you don’t know where to start or are just seeking validation or extra capacity to your own clinical safety work. Please contact us to discuss how we may be able to support you.