Rumex International Co. has attained the new certificate ISO 13485:2003 for the design, manufacture, sale of surgical, microsurgical instruments and medical devices, including ophthalmic and cardiovascular instruments.
Certificate of Quality Management Systems thus added to the bunch of existing ISO 9001:2008, FDA certificates, which make our quality management system comply with the most demanding world-wide quality standards such as requirements of Canadian, UK, US associations and Notified Body.
During the standardization we demonstrated the implementation, maintenance, and effectiveness of a medical device QMS that identifies, manages, and minimizes risks associated with the manufacturing of medical devices and related services and consistently meets customer requirements.
The audit was held by well-recognized audit company specialized in medicine devices area which has best qualified experts and a long successful history of certifying in Russia and CIA, as well as the experience in the US and European markets.
Many processes were honored as exemplary, namely precision CNC equipment, laser welding, engraving, electroplating with thermal operation, fitter's work under the microscope.
This achievement makes Rumex International Co. one of the globally selected providers of microsurgical instruments and medical devices providing and guaranteeing to the customers the highest level of the design, manufacture, quality, sales and customer service.
We strive for the continuous improvement of the quality of our products and services. And now we’re thankful to our numerous customers for the trust that helps us progress.
“I fulfilled the audit of company Rumex Instruments according to the standard ISO 13485. Audit was very complicated: I checked the factory and international sales and marketing.
There is interesting combination of technologies. Unique medical instruments for microsurgery made by unique specialist. System, processes and documents are at the highest level. Thanks to all Rumex staff for a great company and work together!”
Senior auditor ISO9001, ISO13485, ISO27001, СЕ-marking