Quality information

ISO13485
(Quality management system)- Conditions for safe and useful products -

In order to let our customers use safer and more useful medical devices, we have obtained ISO13485, the international standard for medical devices.
(Medical Division)

What is ISO13485?

"ISO 13485" is a standard for quality management systems applicable to medical device manufacturers and others, and is intended to provide medical devices that meet the required quality and safety requirements to the market.

Objectives of acquiring ISO13485

We as a manufacturer of medical devices and other products, SGS Japan Co., Ltd. (UKAS) has officially certified our company for establishing a system to obtain ISO 13485 certification in order to continue to provide safe and reliable products to medical institutions, healthcare professionals and patients.

ISO 13485
Scope of certification ISO 13485 : 2016
Date of initial registration January 6, 2006
Effective period January 6, 2021
Scope of registration
  1. Manufacturing Control and Repair of Cooling Instruments for Physical Practice
  2. Sale and repair of massagers
  3. Design, import, sale and repair of ultrasonic bone density measuring equipment
  4. Design, Manufacturing Control and Repair of Ultrasound Fracture Therapy Instruments and Cross Ligament Functional Testing Instruments
  5. Import, sale and repair of passive exercise equipment for active lower extremities, general purpose ultrasound diagnostic imaging equipment and low frequency therapy equipment
Certification body SGS Japan K.K. (UKAS)

Post-Acquisition Initiatives

We operate our "Quality Management System". To achieve the following "Quality Policy", all of our employees will work together to ensure proper operation, maintenance and management, and provide even better products. We ask for your continued patronage of our products.

Nippon Sigmax Quality Policy

In order to win the satisfaction and trust of customers in the fields of medical care, sports and healthcare centered on the physical activity support business, we consistently perform our work with integrity, provide superior quality products and services, and achieve sustainable development and social contribution.