In many aspects, the DIN EN ISO 13485:2012, as it is called in its current version, is congruent with the international standard for quality management, the DIN EN ISO 9001. Compared to the latter however, it sets out additional requirements such as, among other things, product traceability, introduction of risk management processes, the validation of manufacturing software, maintenance and monitoring, validation of product design and development as well as measures for sterility and cleaning. This discerning quality management system has a decisive advantage for our clients: they can rely on the entire product range to correspond with the highest quality and safety standards.
Everyone has heard about it, but most do not know what it means: the CE label, without which no product whatsoever can be placed on the market in the European Union. For patient safety reasons, the requirements for medical devices in particular are extremely strict.
For the latter, the CE label verifies conformity with the corresponding European guidelines, for example in regard to risk safety and usability. An independent testing and certification authority is in charge of the positive conformity assessment of the Memmert INCOmed CO2 incubators and the S hot air sterilisers. Moreover, the certified QM system in accordance with ISO 13485 is an imperative requirement for the distribution of medical devices.
