NHS Digital have published standards for clinical risk management of health IT systems that are mandatory for health and care in the UK and synergises with international standards relating to medical devices.
Digital health interventions are increasing at pace to support health and care professionals and patients using safe and effective technology. The need for compliance with these standards has never been more important. This includes the overlap into and from MedTech and Medical Devices manufacturers.
Implementing the manufacturers DCB 0129 standard can be daunting and complex for innovators. ETHOS Director Stuart Harrison co-authored the standards and continues to lead their next stage development internationally.
The handpicked team at ETHOS is led by the best in the field and you will be guided through the implementation of the standard in a way that respects your deep knowledge of your product development lifecycle. Our approach seeks to build confidence and competence in your workforce, your greatest asset.
ETHOS provides Clinical Safety Officers who are suitably qualified and highly experienced health care practitioners (Nurses and AHPs). We will work with the strengths of your team, systems and processes to ensure solutions are practical, efficient and become part of business as usual. Culture change is a core element of successful safety systems driving efficiency and it provides reassurance to your customers and end users.
ETHOS team have carried out clinical workflow analysis for a wide range of implementations. We also have a deep understanding in the context of implementing within NHS provider organisations seeking to build capacity in DCB0160 safety work.
Compliance work includes:
• DCB 0129 & DCB 0160 internal audit and review reporting
• Creation of Clinical Risk Management System(s)
• Creation of Clinical Risk Management Plans and Clinical Safety Case Reports
• Integration of the requirements of DCB 0129 into Medical Device Quality Management Systems and Technical Files
• UK NHS Compliance strategy
• NHS App Library Digital Assessment Registration and Submission
• NHS tender and procurement assistance
ETHOS will assess your most immediate needs and develop a roadmap to support your compliance work requirements. The team collaborate regularly with regulatory bodies and professional standards organisations to influence best practice across the health and care sector.