Certification according to DIN EN ISO 13485
Relyon plasma successfully certified according to DIN EN ISO 13485 and DIN EN ISO 9001
Relyon plasma from Regensburg, a subsidiary of TDK Electronics, successfully obtained DIN EN ISO 13485 and DIN EN ISO 9001 certifications at the end of 2020. TÜV SÜD thus certifies the company’s quality management system for medical devices for the very first time.
Regensburg. In line with the new corporate goals, relyon plasma has converted its quality management system to the requirements of ISO 13485 in recent months and successfully implemented the adaptations. Following the positive audit by TÜV SÜD, relyon plasma GmbH has now received certification in accordance with DIN EN ISO 13485:2016 in addition to certification in accordance with DIN EN ISO 9001:2015.
From industrial supplier to medical device manufacturer
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 research 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.
Focussing on the customer
Thanks to this certification from independent TÜV SÜD Product Service GmbH, not only customers from the medical technology sector can be sure that the quality management system and in particular the development meet the high regulatory requirements. This covers all areas from application technology in dental and medical technology to sales and service of plasma systems for surface treatment and activation, including equipment for decontamination in dental and medical technology.
“Our medical technology customers thus benefit from our many years of expert knowledge and have access to compliant products of the highest quality for integration into their own applications,” says Dr. Stefan Nettesheim, summarizing the advantages for customers.
Furthermore, relyon plasma continues to focus on innovation, which is now sustainably supported by the backbone of the consistent application of the management system.