Regulators are becoming increasingly concerned about cybersecurity as markets for smart medical devices grow. Many have now issued security regulations requiring the use of network security tests prior to obtaining pre-market approval.
In 2021, our laboratory in Taipei performed a suite of cybersecurity tests on Sound Land International’s ES-2020 electronic stethoscope. Following this evaluation, the subsequent report helped the ES-2020 gain pre-market approval from the Taiwan Food and Drug Administration (TFDA). More recently, it has now also obtained US Food and Drug Administration (FDA) 510K pre-market approval.
Shao Weizhong, General Manager of Sound Land International, expressed his gratitude to us for actively assisting Sound Land in the verification of its stethoscope products, and for quickly, accurately and efficiently providing the information needed for certifying medical devices. He commented: “Sound Land will continue to develop more related medical equipment products. In the future, with SGS Brightsight’s help, I believe the process of certification will be smoother.”
Steven Chiou, Managing Director of SGS in Taiwan, said: “Because medical equipment is highly regulated, we need to consider electrical safety regulations, electromagnetic compatibility, wireless communication, biocompatibility, software validation and information security, etc. before certification.
“SGS has been active in Taiwan for 70 years. We are constantly developing new compliance testing solutions to assist the medical device manufacturing industry as it transforms into a high value global market.”
About Sound Land International
Sound Land International has over 40 years of experience in developing and producing electronic equipment. As part of a joint venture with Japanese electronic musical instrument manufacturer Roland, it has been producing music processors and audio musical instruments under the Roland and BOSS labels. In recent years, it has also established its own brand and entered the smart medical instrument market.
About SGS Brightsight
SGS Brightsight joined the SGS Group – the world’s leading testing, inspection and certification company – in 2021. With over 35 years of experience, and a growing global network of state-of-the-art laboratories, we provide comprehensive training and evaluation solutions to operators in all industry sectors. We operate 55+ laboratory setups, employ 170+ specialist security evaluators, and perform 700+ evaluations a year – making SGS Brightsight the number one independent security evaluation service provider in the world.