Mosbach, 05.06.2020 – In the Life Science sector, purity and reliability of the manufactured products are indispensable. Therefore, ISO 13485 and 21 CFR 820 requires businesses to use the risk management. A risk management system is intended to support businesses in maintaining high quality standards for their products and thus to avoid risks for patients and users.
The industry solution HYDRA for Life Science supports regulated manufacturing companies with an application for Failure Mode and Effect Analysis (FMEA), a targeted method to detect failures as early as possible. The creation and analysis of failure nets helps this process. The risks arising from the defects can be assessed using key figures, including the severity of the defect sequence, the probability of occurrence of the cause and of detecting a defect. In addition, countermeasures can be defined and traced.
More about HYDRA-FMEA at http://mpdv.info/-