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23 February 2017

KUMAVISION at MedTec: ISO, MDR, UDI - always well prepared

KUMAVISION will be presenting answers to urgent questions in the medical technology sector at Medtec in Stuttgart (Hall 3 / Stand C28). The ERP specialist has prepared its industry software for medical device manufacturers and distributors to meet the new quality management requirements of ISO 13485: 2016. But other current topics and trends such as the Medical Device Regulation (MDR), the Unique Device Identification (UDI) or the digitization of processes determine the ongoing development of the software.

It will be the central challenge for the medical technology industry in the coming year - especially in SMEs: the new ISO 13485: 2016 standard. With the revised standard, all processes related to the quality management of medical device manufacturers and their suppliers must be developed as part of a risk-based approach. This requires a significant expansion of risk management compared to the previous standard, which has only considered risks within product development and product realization as part of the management system. "This point has a major impact on the ERP software used in medical technology, which controls a large part of the processes," explains Jürgen Baier, Head of Healthcare Solutions at KUMAVISION. "That's why we've been following the development of the new standard closely and are incorporating it into the evolution of our industry solution, so our customers can count on them to receive the best possible support in the rapidly changing environment." For this, the existing QM module was rebuilt and functionally expanded. For example, the Failure Mode and Effective Analysis (FMEA) is included. The standard risk analysis and assessment process is an effective tool for implementing the risk-based process development approach.

KUMAVISION documents own processes

Since the suppliers are also expressly covered by the new standard, KUMAVISION not only has to adapt the process control of the software, but also documents its own value creation processes within the release management. Thus, KUMAVISION can support customers in maintaining their QM system. "As one of the most powerful partners for Microsoft Dynamics NAV in German-speaking countries, we are able to implement the requirements of the new standard quickly and reliably and to support our customers in the auditing process," said Baier.

New rules of MDR mapped

The situation is similar with the Medical Device Regulation (MDR). It replaces the previous medical device regulations and brings massive changes. Among other things, the classification rules for medical devices have been renewed. Therefore, every product has to be reassessed. Requirements for various processes, such as the reprocessing of single-use products, have been increased and the documentation requirement intensified. There are also new rules regarding traceability, product identification for labeling and unique device identification (UDI) codes. Companies have to expect unannounced audits at any time. Here, too, KUMAVISION reacted early on and is mapping the new requirements in its industry software. "Much of it has been part of our software for years, and we're taking another one out of current circumstances - in any case, we will provide our customers with expert consultants and a system that will not have to worry about more stringent requirements now and in the future," says Baier ,

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