Qisda the first in Taiwan receives MDR certification for its medical ultrasound products

Qisda Group has announced that its medical ultrasound products have received EU Medical Device Regulation (MDR) certification within one year, making it the first company in Taiwan to receive MDR for medical ultrasound, demonstrating the quality of its medical ultrasound products in compliance with the strictest EU regulations and, most importantly, gaining access to the EU market.

The European Union has replaced the previous Medical Devices Directive (MDD) with the more stringent MDR, which requires post-market monitoring and post-market clinical tracking of medical devices, and is far more mandatory and stringent than the previous MDD, making it extremely difficult to obtain verification.

In recognition of this important milestone, SGS, the world's leading certification body, and Qisda held a certification ceremony on 18 October, which was attended by Chih-Hung Chiu, President of SGS Taiwan, and Spark Huang, General Manager of Qisda's Medical Devices Products Group.

According to Huang, the MDR certification of the entire medical ultrasound product line was achieved at the same time, and the certification was completed with high efficiency. The average time to obtain MDR certification is 18 to 24 months, but the company completed the certification within one year, which demonstrates its professionalism in the field of medical imaging, as well as Qisda's commitment to the innovation of medical equipment, quality, and compliance with regulations.

He further pointed out that with Qisda's strong R&D capabilities in medical device commissioned development and manufacturing services (CDMO), as well as its rich experience in design, manufacturing, regulations and clinicals, Qisda will be able to help more customers accelerate the time-to-market of their medical devices.

Qisda is the first company in Taiwan to receive MDR certification for its entire medical ultrasound product line, and is committed to integrating electronics technology into the medical industry, providing top medical technology solutions, and helping the medical industry become smarter. As it continues to innovate and grow in the healthcare industry, Qisda will maintain its strong commitment to regulatory compliance and continue to drive excellence in healthcare innovation.

Visit BenQ/Qisda at Healthcare⁺ Expo, Booth No. M120