Depending on your needs we can act at different process levels in your organization e.g. project management for the design and development of medical devices, set up/writing and maintenance Design History File (DHF), product risk management according to ISO 14971, coordination of pre-clinical safety evaluation, scientific writing (e.g. biological safety overall summary report, literature review), process validations (e.g. production, packaging, shelf life), European and international regulatory and strategic planning, writing technical documentation and submissions for market approval, communication with the authorities, set-up/implementation and maintenance of Quality Management Systems (QMS), coordinating management review meeting, providing training and coaching, and QMS auditing