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.

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.

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.

​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.

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.

Research and development to offer the innovative solutions will be always the priority of PRODORTH to which “R&D” initials were adopted.

PMS

Customer Feedbacks

Compliance, Regulations

Design

Research & Development

Transfer of design to production

QUALITY

MANAGEMENT

Purchasing

Conformity of suppliers

Conformity of raw materials

Storage & Logistic

Packaging control

Final quality control

Production

Machining, Cleaning, Anodizing,

Lazer marking control

prodorth spine
prodorth spine
prodorth spine
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CE CERTIFICATE
ISO 13485:2016 IMPLANTS
SO 13485:2016 INSTRUMENTS
FSC INSTRUMENTS
FSC IMPLANTS
PRD + TRADEMARK
PRODORTH TRADEMARK
S33 + TRADEMARK

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.

prodorth spine