8foldGovernance

Healthcare compliance with a human touch. Our team draws on far-reaching expertise in healthcare compliance to support you on your journey. We believe compliance means more than meeting a checklist of requirements – organisations' governance, leadership, and culture play an essential role in creating better healthcare outcomes. We work with companies of all sizes, helping you find a route from where you are to where you need to be. With diverse expertise and experience, we can help you embrace “good governance” without distraction. With expertise in: AI Governance and Regulations (ISO 42001 - EU AI Act) Medical Device Regulations (Covering the UK/EU/US - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - Technical File Creation - Clinical Evaluation - Notified Body Engagement - Ongoing Quality Management Support) International Standards (ISO 27001 - ISO 9001 and more) Data Protection Regulations (UK/EU GDPR - NHS Data Security Protection Toolkit - DPO) NHS Clinical Safety (DCB0129 - DCB0160 - Clinical Safety Officers) NHS Digital Technology Assessment Criteria (DTAC) Care Quality Commission (CQC) Regulations (Initial Registration - Gap Analysis - Ongoing Quality Management Support) Cyber Security (Cyber Essentials - Cyber Essentials + - CREST Penetration Testing) Our team of domain specialists will handle every detail, helping you to focus on what you do best. We go beyond the tick box to put safety, ethics and good governance at the heart of every healthcare innovation. Get in touch to find out how we can support you. For Patients. For Healthcare. For Good.