We Have Obtained ISO 13485：2016 Certification

1 day ago
1 min read

Our company has obtained certification for the international standard ISO 13485：2016, a quality management system standard specific to the medical device industry, on March 30, 2026.

ISO 13485：2016 provides the foundation for quality management practices in medical device regulations worldwide, including those in Japan.

We will continue to strengthen our quality management system while advancing digital transformation in healthcare.

■ ISO 13485：2016 Certification Registration Details

Registered Organization: Southwood Inc.　Tokyo Office

Scope of Registration: Receiving, labelling, storage, and distribution of general imaging ultrasound systems

Certification Body: BSI Group Japan K.K.

Registration Number: MD 834336

Certification Date: March 30, 2026

■ Contact Information

info@southwood.co.jp

Comments

We Have Obtained ISO 13485：2016 Certification

Our company has obtained certification for the international standard ISO 13485：2016, a quality management system standard specific to the medical device industry, on March 30, 2026 . ISO 13485：2016 provides the foundation for quality management practices in medical device regulations worldwide, including those in Japan. We will continue to strengthen our quality management system while advancing digital transformation in healthcare. ■ ISO 13485：2016 Certification Regis

1 day ago

We Have Obtained “Certification for a Designated Specially Controlled Medical Device.”

On March 11, 2026, our company obtained the “Certification of Designated Specially Controlled Medical Devices.” We are dedicated to accelerating the integration of AI-assisted ultrasound diagnostics into the healthcare system. ■ Details of the “Certification of Designated Specially Controlled Medical Devices.” Certification Number: 308ACBZX00005000 Marketing Authorization Holder: Southwood Inc. Certified Product: Ultrasound Image Display Software “Southwood” Certification Dat

Mar 31

A Pilot Study on Remote Ultrasound Using the “Butterfly iQ3™” Was Conducted

Southwood Inc. (Headquarters: Tokushima City, Tokushima Prefecture; Representative Director: Kenya Kusunose), a licensed distributor of the portable ultrasound diagnostic device “Butterfly iQ3™” manufactured by Butterfly Network, Inc. (U.S.), conducted a remote echocardiography demonstration (pilot study) on March 6, 2026, at University of the Ryukyus Hospital and Okinawa Prefectural Yaeyama Hospital, with real-time connectivity between both locations. In this pilot study of

Mar 17

We Have Obtained a Secondhand Goods Dealer License

Mar 17

We Have Obtained ISO/IEC 27001 Certification

Our company has obtained certification for the international standard ISO/IEC 27001, which relates to Information Security Management Systems (ISMS), on March 3, 2026. ISO/IEC 27001 is an international standard that provides a framework for organizations to effectively manage information by ensuring an appropriate balance of confidentiality, integrity, and availability, thereby enabling the secure and efficient use of information. We will continue to appropriately manage ou

Mar 11

We Will Participate in “DEEPTECH STARTUP PITCH in TOKYO” Hosted by Tokushima Prefecture

Our company will participate in the “DEEPTECH STARTUP PITCH in TOKYO,” which will be held in Tokyo on Thursday, March 12, 2026. ■ Event Overview “DEEPTECH STARTUP PITCH in TOKYO” is a pitch event where Tokushima Prefecture’s leading deep-tech startups present their technologies and future potential to investors and organizations seeking new investment and collaboration opportunities. This event offers a firsthand look at the forefront of innovation emerging from Tokushima, as

Feb 13