Quality Management
In our opinion, “A sustainable quality mentality” is the most critical fact for the permanency of a company. The main approach of PRODORTH is to maintain high quality products for the long run, an approach which aims at earning trust and building loyalty with our customers who we aim to serve for the long term.
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Instead of using these certificates just as keys for trade, we prefer managing our business according the requirements of these systems. ISO 13485:2016 Quality Management System is efficiently adapted on the organization of PRODORTH and provides a 100% traceability from initial to final product.
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Our main task with respect to Quality Management is ensuring a complete control in a reliable and continuous production quality with machining, polishing, washing, color anodizing and laser marking units within our organization.
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​Biomechanical and biocompatibility tests were performed in accordance with ASTM and ISO standards which are required to launch our products to the market reliably, in addition all Prodorth products are firstly used by our surgeons and only launched to market after the succesful clinical outcomes are obtained.
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PRODORTH has identified the problems during surgical operations and contacted surgeons on this issue. These feedbacks and internal discussions, analysis and wide researches provide new approaches which leads to new ideas.
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Research and development to offer the innovative solutions will be always the priority of PRODORTH to which “R&D” initials were adopted.
Research & Development
Transfer of design to production
Customer Feedbacks
Compliance, Regulations
QUALITY
MANAGEMENT
Conformity of suppliers
Conformity of raw materials
Packaging control
Final quality control
Machining, Cleaning, Anodizing,
Lazer marking control
EU Medical Devices Regulation 2017/745 - MDR
MDR (2017/745) is a regulation on clinical research and sale of medical devices.
The purpose of this regulation is to determine the procedures and principles regarding the protection of the health of patients, users, and other persons, as well as ensuring high quality and safety standards in medical devices.
​​​​​​​As it is known, the Medical Device Regulation (MDR) No. 2017/745 (EU) entered into force by being published in the EU Official Journal Gazette on 25 May 2017. It was foreseen to be implemented by 26 May 2020, but due to the coronavirus pandemic, the date of implementation and the repeal date of the current directives (MDD) have been updated to 26 May 2021.
PRODORTH maintains a “sustainable quality understanding" for all our staff in terms of preparations for MDR process. In order to fulfill the new obligations of MDR, we try to combine "teamwork" and "quality awareness" to ensure the safety of our products.
”A sustainable quality mentality”
All our manufacturing processes are followed up and managed in accordance with the medical device directive 93/42/EEC and a well-established ISO 13485:2016 system. At the same time, the transition to the 2017/745/EC Medical Device Regulation (MDR) is in progress.
