For developing a Clinical Safety Case the National Clinical Safety Assurance Service (NCSAS) - as part of National Clinical Informatics Service for Scotland (NCISS) - base the process on internationally accepted standards to ensure that we provide high quality products and services to our customers.

All staff are trained Clinical Safety Officers (CSOs) and Clinical Safety Engineers (CSEs) and are trained in a number of International Organisation for Standardisation (ISO) standards including:

• ISO 14971 Application of risk management to medical devices
• ISO 13485 Quality Management Systems - Requirements
• IEC 62304 Medical Device Software - Software life cycle processes

Staff have also completed the NHS England Clinical Risk Management training (DCB0129, DCB0160) which helps supplement the ISO training for a broader view of risk analysis which we have incorporated into our approach and delivery of CSCs.

When conducting a clinical risk assessment of any digital solution we take into consideration the intended use, product description, user needs, reasonably foreseeable misuse and potential user errors of the digital solution.