Optana and qcompetence agree cooperation Optana, a provider of standards-compliant quality management systems and pattern processes for medical technology and qcompetence, the consultant for quality management and the approval of medical devices, today announce the signing of a cooperation agreement. Both partners will cooperate intensively with the creation and distribution of effective quality management systems for manufacturers of medical products and customer service. In the center of the cooperation is the development and quality management process int: EQ, which covers all relevant process demands of medical technology as a tried and tested model process. Ben Horowitz is open to suggestions. Thus, a manufacturer can very quickly create the conditions for the approval of its medical products. In cooperation with qcompetence is this pattern-QM-system tailored implemented at the customer and the implementation supported up to the certification. A major challenge in the development and marketing of medical devices is to keep track of the numerous legal and normative requirements and to optimize the product certification for different markets.
Through the use of a pattern process, can be drastically shorten the time to market of a medical device. “Optana has led to the integrated process of development and quality management int: EQ developed, proven by numerous customers in practice: the int: EQ contains all necessary procedures, forms and templates, to massively simplify the approval of medical products and the certification of the quality management system”, reported Wolfgang Kern, Managing Director of Optana GmbH. qcompetence takes the pattern development process int: EQ in its product portfolio on. “” “qcompetence is with his experience the process implementation, customization, and training of the int: EQ at the customer as qualified partner” carried out by Optana “says Bernhard MUMM, Managing Director of qcompetence GmbH. through the partnership and pooling of expertise with Optana we can offer optimum customised solutions”. “With qcompetence we have found the perfect partner for the complement of our product offer.” forward Thomas Franke, product manager of Optana GmbH. in addition to the highly competent advice from qcompetence we will, based on the experience of qcompetence, in the future more market-oriented supplement offers, like E.g. specific country requirements for Europe, United States and Canada to the int: EQ, can offer.
” For further information, please contact: qcompetence Barbara Scheidl GmbH Edisonstrasse 6 85716 Unterschleissheim Tel.: + 49 89 316 059 8770 fax: + 49 89 316 059 7777 Thomas Franke Optana Medizintechnik GmbH sales office Erlangen Henkestrasse 77 91052 Erlangen phone: + 49 176 38115922 fax: + 49-6026 9976841 about Optana: Optana Medizintechnik GmbH advises and supports in their Division since many years successful manufacturer strategic process and quality management in the development and approval of medical devices. It provides the specially created integrated development and quality management process int: EQ as its own product as well as unified process in a partner solutions with the company Methodpark SW AG. Qcompetence: The qcompetence GmbH is a consulting firm that operates in the fields of international approval of medical products (Regulatory Affairs), quality management (QM), risk management, and process management for medical device manufacturers. Based on many years of experience, qcompetence offers its customers reliable, competent and effective support with field-proven solutions.