Quality management system for medical devices, the ISO 13 485 standard and the impact of the new RDM 2017/745 regulation
A quality management system applied to medical devices is governed according to ISO 13485. This non-mandatory standard applies to organizations involved in one or more stages of the life cycle of a medical device ranging from design to development and also including production, storage, distribution and post-market surveillance. Companies working on the recycling of these products are also concerned.
Will your business be affected by the RPA?
Among the best known, we find printing which (among other things) replaced manual copying and marked the disappearance of copyists, tractors which deprived draught horses of their last utilitarian role, driving them to the brink of extinction, and the digital camera which almost replaced the analogue camera and contributed to the bankruptcy of the company which saw its birth (Kodak)! There are many examples and it is legitimate to ask the question about the RPA as well.