Summation
- The Medical Device (MDR) Regulation (EU) 2017/745 was issued in May 2017, compared with the MDD directive, the MDR regulation has stricter and more comprehensive requirements for medical devices, and the pre-market certification review is more difficult and the certification cycle is longer, and all those changes has raised the threshold for certification.
- The MDR certification acts as a catalyst for Wandong Medical to expand its coverage in the international market, accelerate the process of globalization, and contribute Chinese solutions to the health of people around the world.
- Wandong always follows a high level of standard, and the full range of X-ray, CT and MRI products have been completed certification of CE MDR.
Recently, Wandong’s seven major series of products obtained the MDR certificate, following the completion of the first MDR certification for superconducting magnetic resonance.
So far, Wandong’s full range of X-ray, CT and MRI products have been completed the switching from CE MDD to CE MDR.
High standards define high reliability
CE certification, as a “visa” for products to enter the European market, is a mandatory requirement for product access in the EU market. The Medical Device (MDR) Regulation (EU) 2017/745 was issued in May 2017, compared with the MDD directive, the MDR regulation has stricter and more comprehensive requirements for medical devices, and the pre-market certification review is more difficult and the certification cycle is longer, and all those changes has raised the threshold for certification.
Wandong always follows a high level of standard, and the full range of X-ray, CT and MRI products have been completed certification of CE MDR.
Established in China, Impacting the World
Wandong Medical, as a professional manufacturer in the medical imaging industry, always adheres to technology innovation, continuously improves its quality management, and is committed to launching high-quality, high-performance, reliable products for customers all over the world.
The MDR certification acts as a catalyst for Wandong Medical to expand its coverage in the international market, accelerate the process of globalization, and contribute Chinese solutions to the health of people around the world.
Beijing Wandong Medical Technology Co.,Ltd has dedicated itself to the R&D, manufacture, sales and service of medical imaging equipment for nearly 70 years. In addition to a wide sales and service network all over China, our export destination covers more than 70 countries. With strict production and quality management, our MRI systems and major X-ray equipment are ISO/CE/FDA cleared. Over 8500 units of equipment are manufactured annually.
The company philosophy, “Precision and Vision”, is our motivation to strive for advancement and innovation.
