QUALITY MANAGEMENT

Quality Management

A sustainable quality mindset is essential for long-term success at Prodorth. Our focus is on delivering consistently high-quality products that build trust and lasting partnerships with our customers.

Rather than treating certifications as formal requirements, we fully integrate ISO 13485:2016 Quality Management System into our operations, ensuring complete traceability from raw material to final product. All manufacturing processes—including machining, polishing, washing, anodizing, and laser marking—are performed under strict quality control within our facilities.

All products undergo biomechanical and biocompatibility testing in accordance with ASTM and ISO standards and are clinically evaluated by surgeons before market release. Continuous feedback from surgical practice, combined with in-depth analysis and research, drives our innovation process. For PRODORTH, R&D remains a core priority in delivering reliable and forward-looking spinal solutions.

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.

01 — Incoming Quality Control & Full Traceability System

Prodorth Spine’s spinal implant quality control process begins with incoming raw material inspection. All materials received from suppliers are subjected to Incoming Quality Control procedures in compliance with ISO 13485:2016 Medical Devices Quality Management System requirements.

Each raw material is assigned a unique LOT number to ensure full traceability. During production, every semi-finished product is linked to a dedicated work order number, enabling systematic process monitoring and documentation.

From raw material acceptance to final product release, full backward traceability is maintained, ensuring transparency and control throughout the medical device manufacturing process.

03 — Final Product Verification, Risk Management & MDR Compliance

Prodorth Spine operates under ISO 13485:2016, complying with Medical Device Directive (MDD) and European Union Medical Device Regulation (MDR) requirements for the design, manufacturing, and sales of spinal implants. Design and development processes are conducted in alignment with user needs, clinical requirements, and MDR General Safety and Performance Requirements.

Risk management activities follow the ISO 14971 framework, covering all stages of the product lifecycle. Potential risks are identified, analyzed, reduced to acceptable levels, and fully documented.

From raw material acceptance to final product release, all stages are recorded to ensure full traceability and regulatory compliance in medical device manufacturing.

02 — In-Process Inspection & ISO 2859-1 Compliance

During spinal implant manufacturing, all semi-finished products are inspected by quality control personnel in accordance with ISO 2859-1 sampling standards. Product conformity to technical specifications and defined quality criteria is systematically verified.

At the finished product assembly stage, each product assembled according to customer orders is assigned a separate LOT number. This LOT number is permanently applied to the product via laser marking, ensuring physical and documented traceability.

All production and inspection activities are recorded, maintaining continuity and consistency within spinal implant quality control procedures.