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As a manufacturer of medical devices, you are met with many requirements and comprehensive regulation. It is a determining factor that you begin the process correctly and consider legal requirements for product and quality management, from the beginning of the development phase. To be able to meet the different test standards within EN 60601 or IEC 60601 family, you must be able to document product development according to standardized risk management in accordance with ISO 14971. Moreover, a number of supplementary tests are required: software, usability, mechanical and climatic, and of course EMC and safety.