ABOUT US
S33 Spine which has been developed based on our spinal implants manufacturing and brand-management background with a years of experience is a sub brand under Prodorth umbrella. The products of S33 Spine are manufactured with perfection to match our high quality standards. We developed alternative solutions to offer affordable prices by data transfers from Prodorth’s infrastructure such as technical files, technical drawings, established workmanship organization, ads design etc. Teamwork, enthusiasm and dedication are crucial for the sustainable success of S33 Spine. We guarantee added value for our users and clear competitive benefits for our distributors.
RD Medikal is the name of the company where commercial brand names Prodorth and S33 Spine products are produced. It was founded in 2013 by Mechanical & Materials Engineers, as well as the contribution of the healthcare professionals.
Within our journey, we always tried to follow up the latest technologies by combining them with the user-friendly approaches which are the accepted and well-known methods by surgeons.
We always try to provide the most simple instrumentation not only to carry out the surgical procedures simply but also to obtain the most efficient solutions and to provide patients and surgeons with our progressive spinal medical devices with RD MEDİKAL’s high tech production lines.
Quality Management
ISO 13485:2016 Quality Management System is efficiently adapted on the organization of S33 Spine and provides a 100% traceability from raw material 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.
Our claim is to consistenly develop our products, to keep our quality at the highest level, to ensure requirements of quality management procedures considering countries’ regulatory systems.
We also strive to provide requirements of the MDR(2017/745/ EU) which is the new regulation for medical device companies to sell their products in Europe as well as other countries.
MDR
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, EU 2017/745 Medical Device Regulation (MDR) 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.
S33 Spine 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”
Customer Satisfaction
The company takes part in the biomedical industry with its innovative and high quality products. S33 Spine products are designed, manufactured and developed in our organization, and the results are always met with the approval of well-known surgeons.
S33 Spine began its journey with the principle of “Human First” and always proceed in this way.
Knowledge combined with technology and innovator approach...
“Customer Satisfaction” is not just a catchphrase for us as we aim at maintaining long-term relationships with our customers. Therefore, we are highly aware that we have to provide perfect post-marketing services.
In our opinion high quality should not be a privilege, but rather a standard in the medical industry, hence we are always keen on following up on the latest technologies and keep on investing in our technical staff in order to keep the level of our products’ quality intact.
We reflect the value of our brand to our products and we would like to see the doctors feel our effort of understanding and solving their problems.
High Quality and innovation are the first details you will notice about S33 Spine products.
