Medical Device Regulation and harmonised standards
The regulatory standards and guidance documents below are crucial for ensuring the safety, quality, and efficacy of medical devices in healthcare settings. Here’s a detailed
The regulatory standards and guidance documents below are crucial for ensuring the safety, quality, and efficacy of medical devices in healthcare settings. Here’s a detailed
IEC BS 42001 IEC BS 42001 is a standard for Artificial Intelligence Management Systems (AIMS). It provides a framework for organizations to manage AI systems
Artificial Intelligence (AI) is a broad field of computer science focused on creating systems that can perform tasks that typically require human intelligence. Here’s an
Overview Clinical Risk Management (CRM) governance is crucial in the development, deployment, and use of digital health technologies within the UK healthcare sector. It ensures
A clinical risk management file in relation to DCB0129 and DCB0160 NHS safety standards is a comprehensive document that outlines the approach to identifying, assessing,
DCB0129, otherwise known as “Clinical Risk Management: its Application in the Manufacture of Health IT Systems”, is a standard that provides a framework for Digital
Overview of NHS Digital Clinical Risk Management Standards The NHS has established two key standards for clinical risk management in digital health: These standards are
Introduction to Digital Health Systems Historically, we referred to Health IT systems; today, we embrace the era of Digital Health systems or Digital Health technologies. This evolution reflects our