Medical Devices Act
To market and sell devices in the field of medical engineering within the EU, the manufacturer is obliged to comply with DIN EN 13485. If products are supplied to the US, the requirements of 21 CFR 820 must be met.
Taking into account the relevant rules and regulations, we will realize efficient implementation of the required standards and directives for your product in close collaboration with you.
Upon definition of the critical quality attributes (CQA) and process parameters (CPP) and a resulting design space FMEA and measurement system analysis, all relevant requirements for product manufacturing are specified in the user requirement specification (URS). The subsequent selection of suppliers and the qualification documentation form the basis for a sound automation solution for your medical devices. After fabrication of the automation solution through plant and test equipment qualification, as well as process validation, the quality certification will be documented.