We're taking big steps to leave its quality seal in China, a rapidly evolving market that’s expected to form 20% of the global market in 2030. Behind this progress stands our Applus+ Laboratories team, who have joined forces from Germany to Shanghai to put together a newly accredited medical device testing laboratory in Shanghai in record time and under stringent conditions.
China’s medical device market is booming, but there’s still ground to cover. The machinery needed to test implant materials and components according to major international standards is still rare to find in this region. This takes us to our first major challenge: quickly transferring the knowledge about the functionality, proper use, and proper testing machinery use to Shanghai.
"Finding common ground between the Chinese and German working cultures was tough, as well as working with a six-hour time difference. But we had one leitmotif, and that was to get accreditation on time," says Morgan Xia, who's proudly earned the role of - Manager at our medical device laboratory in Shanghai.
The next big step was receiving accreditation and managing the bureaucratic paperwork with a tight deadline: May 2023. Meeting this deadline turned into a bigger challenge due to two reasons. Our medical device testing machinery built in-house was delayed due to delays with importation conflicts. Additionally, not just ours, but several projects were put on hold in the region due to China’s three-month confinement between March and May 2022.
Each project phase was extensive and unique, but there was one common denominator: our team’s determination to reach accreditation on time.
The first step was conducting an extensive evaluation to understand where to place the lab, the ideal proportions, and the test room structures- among other characteristics. In this phase, Robert Paul and Marcel Knothe from our German headquarters connected with Morgan Xia in Shanghai through several online training meetings to get insight into test methods, equipment operation, quality requirements, etc.
The following four months focused on machine manufacturing and putting the lab together. Once built, it took the Applus+ Laboratories team three months to install the machinery. This machinery would then be used by Morgan and Robert as they travelled from China to Shanghai to establish technical procedures and training. The knowledge was then passed on to the rest of the staff to ensure proper equipment use, a phase that was significantly enhanced thanks to increased connectivity and augmented reality techniques.
After this extensive process, our medical device lab in Shanghai was accredited under ISO/IEC 17025:2017 standards. Currently active in hip and knee testing, this lab is also ready to test under 30 international and more than 20 national Chinese standards that include testing for ankle, dental implants, and trauma products.
But none of these accomplishments could have been made a reality without the efforts of our team joining forces. "It was only possible thanks to above-average commitment, absolute enthusiasm and dedication, and hard work from both teams. They adjusted their working hours to meet remotely and adapted to the working hours once on site” says Robert Paul, Deputy Lab Manager at Applus+ Dresden.