Digisafe

DigiSafe helps Digital Health and Care organisations achieve clinical safety, assurance, and compliance - led by experts! We support Digital IT manufacturers, innovators, and Health & Social Care providers in meeting their Clinical Safety and DTAC requirements, with a focus on the mandated standards DCB0129 and DCB0160. Our team of Digital Health, AI, and Clinical Safety Specialists combines regulatory expertise with real-world experience across health and care settings. We work alongside clients to embed safety, assurance, and governance into everyday operations — ensuring digital solutions, including AI and ambient technologies, are safe, compliant, and designed around the needs of patients and professionals. At DigiSafe, we believe in digital enablement, inclusion, and patient safety. These principles guide every service we deliver, helping organisations confidently adopt innovation while protecting users and maintaining compliance. Our expertise spans: Clinical Safety & Governance frameworks AI and Ambient Service Safety Assessments DTAC and Medical Device compliance EPR and Shared Care Record deployments Digital transformation and assurance modelling With a background in clinical governance, our team understands the real-world challenges of digital health delivery. We ensure your product, service, or deployment meets national and international standards, from concept to implementation. DigiSafe – bridging the gap between innovation and assurance in Digital Health, AI, and Ambient Care.