Daniel is Validation Engineer at NNE Pharmaplan AB and has eight years of experience medical device R&D, process validation and quality support. His experience in medical device R&D includes design development, design verification and validation, product risk management, and associated documentation. Daniel has worked with development and implementation of design control procedures within a quality management system, including procedures for medical device risk management and change control. Furthermore, Daniel has experience as a validation and quality expert medical device manufacturing. Daniels has also experience in risk management working with development and implementation of risk management procedures for medical devices and/or drugs in accordance with regulatory requirements and standards such as ISO 14971, ICH Q2, ASTM E2500 and FDA guidance documents. His responsibilities also included establishment of methods and tools for securing transfer of knowledge gained during the risk assessment process at R&D to process owners responsible for manufacturing. Daniel has on several occasions acted as risk management owner and risk assessment facilitator with responsibility of establishing product as well as process risk assessments and associated risk management plans, reports and files.