Customers: Osstem Implant Seoul; Pharmaceutics, medicine, health care Contractors: Dassault Systemes Product: Dassault License to Cure for Medical DeviceНа базе: 3DExperience Project date: 2016/01 - 2016/03
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On July 4, 2016 the Dassault Systèmes company announced implementation by company Osstem Implant Co., Ltd. industry solution of Dassault Systèmes of "License to Cure for Medical Device" for expansion of a share in global market of the systems of tooth implants.
Project Tasks
The Osstem Implant company set the object to increase a market share due to achievement of balance between observance of regulatory requirements and implementation of innovations. In particular, the unified digital platform for management of unique identifiers of devices (unique device identifier, UDI), changes in design and information on a quality assurance which the company directs for receiving necessary approvals to regulatory bodies, such as Management for sanitary inspection behind quality of foodstuff and medicines of the USA was required for the company.
The industry solution of "License to Cure for Medical Device" created on platform 3DEXPERIENCE provides the integrated business environment for joint work which allows to accelerate an output to the market of the innovation and safe medical devices which are completely conforming to industry standards.
Project Progress
Osstem Implant implemented software and received a uniform source of information, the complex, monitored and conforming to regulatory requirements development processes of products which are directly connected with a quality management system. It allows to minimize production time for the market and influence of regulatory costs.
We decided to use industry solution of Dassault Systèmes of "License to Cure for Medical Device" to optimize our interaction with regulatory bodies and to improve development processes of new products in process of global expansion and with growth of need to conform to different market demands. Thanks to it we will be able to increase efficiency of new product development and project management and also to simplify process of giving in regulatory bodies of documentation on our systems of tooth implants. Tae-Yong Kim, the chief of the department information systems in Osstem Implant |
The industry solution of "License to Cure for Medical Device" allows to turn interaction with regulatory bodies from restriction into a certain asset using which the organizations can optimize the efforts on quality assurance and compliances to regulatory requirements and also to lower costs and to accelerate that time which is necessary for an output of new products to the market. Thanks to these to the complex, completely monitored and completely conforming to regulatory requirements development processes of new products providing opportunities for joint work and directly connected with a quality management system and regulatory information, the companies have an opportunity even more effectively to solve any problems arising during the project and at the expense of it to accelerate creation of the advanced solutions aimed at providing human health. Jean Colombel, vice president of Dassault Systèmes for solutions for the industry of medicobiological sciences |