The Regulatory Science in the Laser Treatment −From Development Engineers’ Point of View

The risk analysis is put into practice at each carrying a stage further according to the quality management system in the development of medical devices. The data that is based on the risk analysis guarantee the safety and efficacy of a product. Also the data is used for submission to approval. Therefore, it is believed that the risk analysis itself and the investigation is the foundation of the regulatory Science in the development of medical devices.