As digital health solutions rapidly become integral to healthcare, adhering to NHS Digital’s clinical risk management standards for health IT systems is crucial for UK health and care providers. These standards, which align with international norms for medical devices, are essential for ensuring the safety and effectiveness of digital health technologies. The complexity of these standards, particularly DCB 0129 for manufacturers, can pose significant challenges for innovators in the field.

ETHOS, under the leadership of Stuart Harrison, who played a pivotal role in co-authoring and evolving these standards internationally, offers unparalleled expertise in navigating these requirements. Our approach is tailored to respect and enhance your product development lifecycle, aiming to foster confidence and competence within your team – your most valuable asset.

ETHOS brings together a team of highly qualified and experienced Clinical Safety Officers, including Nurses and AHPs, to work alongside your strengths, systems, and processes. Our goal is to implement practical and efficient solutions that seamlessly integrate into your daily operations, promoting a culture of safety and efficiency that reassures your customers and end-users.

Our services cover a comprehensive range of compliance activities, from DCB 0129 & DCB 0160 audits and reviews to the creation of Clinical Risk Management Systems and Plans, as well as integrating DCB 0129 requirements into Medical Device Quality Management Systems. Additionally, we offer strategic support for UK NHS compliance, NHS App Library submissions, and tender and procurement processes.

ETHOS is committed to understanding your immediate needs and developing a bespoke roadmap to guide your compliance journey. We actively collaborate with regulatory and professional bodies to advocate for best practices within the health and care sector, ensuring our solutions are at the forefront of clinical safety and effectiveness.

Allow us to assess your most immediate needs and develop a roadmap to support your compliance work requirements

Allow us to assess your most immediate needs and develop a roadmap to support your compliance work requirements. We’ll also collaborate regularly with regulatory bodies and professional standards organisations to influence best practice across the health and care sector.

Contact us today for your free initial diagnostic conversation or Health Check when you get in touch.