Quality management team relyon plasma (from left to right): Andreas Ammon, Katharina Bayer, Geri Richter.
Founded in 2002 as Reinhausen Plasma, relyon plasma GmbH focused on the development of plasma technology for industrial customers. However, with the implementation of Piezoelectric Direct Discharge technology, the customer base has increasingly expanded in the direction of medical technology and subsequently also to medical devices.
In order to meet the requirements of both customers and the regulations, the company decided in 2019 to be certified according to DIN EN ISO 13485 in addition to DIN EN ISO 9001. The EN ISO 13485 standard "Medical devices: Quality Management Systems - Requirements for Regulatory Purposes" deals with the requirements that manufacturers and suppliers of medical devices must fulfill when developing, implementing and maintaining management systems for the medical device industry.
Dr. Stefan Nettesheim, Managing Director of relyon plasma GmbH, comments on the company's development: "For many years we have been supplying industry, universities and re-search institutes with first-class atmospheric plasma systems for surface treatment. Now we are expanding our portfolio on this technological basis specifically for dental and medical technology. Our entire process chain, from development and production to service, has been certified conforming to ISO 13485. In accordance with this quality standard, we now offer our cold plasma modules for integration in medical applications."
Quality management system for medical devices
After the new quality management manual was completed in November 2019, relyon plasma GmbH has used the year 2020 for the fully comprehensive implementation of the requirements of ISO 13485, taking into account ISO 9001. The certification places high demands on exact compliance with all process steps, with particular attention being paid to consistent and complete documentation and risk management. Therefore, the complete organization from design and development, production, installation, maintenance up to sales underwent structural adjustments. From now on, the improved documentation will ensure long-term qualified personnel deployment as well as modern production technology.
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