Quality Management System
In order to maintain consistency between regulatory requirements and customer demands, as well as to ensure that such requirements are satisfied, J-TEC’s "Quality Management System" is a system which plans and implements activities aimed at continuous improvement, in addition to the control and management of the quality of our products and services.
J-TEC believes that not only must we guarantee the high quality, efficacy and safety of our product based on scientific evidence, but we also have the social responsibility to ensure that professionals in the medical field and patients have a stable supply and can feel safe and comfortable using our product. Moreover, in order to satisfy our customers, it is imperative that we provide excellent, high quality products accompanied by appropriate information. In order to be able to satisfy these requirements, we will build and operate a quality management system, establish a "Quality Policy", and as a pioneer in this field, grow and develop our business in a responsible manner.
- J-TEC’s Quality Policy
- In order to develop our Regenerative Medicine Business and R&D Support Business, J-TEC has developed a quality management system which applies the QMS Ordinance for Medical Devices, ISO13485:2003, and ISO9001:2008. This system is constantly being improved to enable us to offer high-quality products of outstanding efficacy and reliability.
Yosuke Ozawa
President & CEO
J-TEC carries out its operations, including research and development/clinical trials, manufacture/inspection, sales and post-marketing surveillance in compliance with ordinances and notifications released by the Health, Labor and Welfare Ministry.
*1 GLP：Good Laboratory Practice (Implementation standards for non-clinical trials related to the safety of medical devices)
*2 GCP：Good Clinical Practice (Implementation standards for clinical trials of medical devices)
*3 QMS：Quality Management System (Quality and manufacturing control standards for medical devices)
*4 GQP：Good Quality Practice (Quality assurance standards for medical devices)
*5 GVP：Good Vigilance Practice (Post-marketing safety control standards for medical devices)
*6 GPSP：Good Post-Marketing Study Practice (Implementation standards for post-marketing surveillance and testing of medical devices)
Monitoring Activities
At J-TEC, we have a division, which is independent from the R&D /clinical testing, manufacturing / inspection, and sales / post-marketing surveillance divisions. This division is building a system to assure the reliability of our testing and quality.
Regulartory Audit
Approval from the Health, Labor and Welfare Ministry is necessary in order to manufacture and sell tissue-engineered medical products. A vast number of documents for the Application for Pre-Clinical Approval and the Application for Pre-Market Approval must be submitted to the proper office for review. These documents are based on test data, and the way in which this data is handled is extremely important. In addition, the reliability of investigations and testing carried out after the manufacture and sale of the product must be ensured. At J-TEC the Regulartory Audit Division carries out investigations and test audits, assuring the reliability of tests related to the efficacy and safety of our products.
Quality Assurance
In order to ensure the continuous improvement of the quality management system, it is necessary to carry out a cross-sectional analysis and evaluation of information related to our products with the various related divisions, and implement appropriate corrective and preventive actions. At J-TEC, the Quality Assurance Division promotes quality management activities through a system which includes not just related divisions, but the participation of every employee throughout the entire product cycle, from research to the development of a commercial product, the procurement of raw materials and the production, sale and usage of the product, and as an auditing agent, guarantees the reliability of our products.Safety Management
At J-TEC, the safety management division collects and reviews information about safety management with respect to commercially sold medical devices (items related to the quality, efficacy and safety and other items necessary for the appropriate use of medical devices) and builds a system which will take the necessary actions to ensure safety. J-TEC is working hard to ensure the safety of patients by swiftly and firmly implementing measures to ensure safety.