DATA MODUL certified in accordance with ISO 13485
DATA MODUL (DMO) works continually on the expansion of its service portfolio and from now on offers medical technology customers substantial added value in the development and production of professional control units for medical applications.
With the ISO 13485:2012, the internationally recognized standard for quality management systems for medical product manufacturers, and the related adjustments that have been carried out – especially of the value-adding processes – to the regulatory requirements of medical technology, DATA MODUL now fulfills all normative conditions for medical product systems right through the product life cycle.
In addition to clear rules in the value creation process, standards create standardized process steps and an internationally valid framework of understanding, for all process owners/partners/suppliers/companies, because a uniform language is being spoken. For the customer this means less time and money has to be spent on additional monitoring. Customers can rely on consistent and documented product quality and safety (e.g. fault prevention by systematic risk management) and also claim a right to them.
Customer requirements are identified and implemented by means of systematic process steps, especially through close communication with the customers. In particular, systematic furnishing of verification and documentation is incorporated in the development and production process for the whole product life cycle, as well as constant risk and safety considerations.