Quality Management

Fukuda enhance its manufacturing technology to continue to maintain outstanding quality of its products with minimal impact on the environment.

Since its foundation, Fukuda has been dedicated to delivering the highest quality and therefore operates a strict quality control system. In recent years, as people have become increasingly safety-cautious concerning medical treatment, Fukuda has drawn up plans to broaden and reinforce its quality control system, basing its own quality system on the Zero Complaint Concept.

ISO 9001/ISO 13485

ISO 9001 is a recognized international standard that specifies requirements for a quality management system, from design and development to production, inspection, shipping and servicing of a product, established by the ISO (International Organization for Standardization).

And in addition, ISO13485 is a recognized international standard that specifies requirements for a quality management system of medical devices, which is widely involved in legislation in various countries in the world.

We, Fukuda Denshi Co., Ltd., have obtained certification of ISO 9001 in 1995, and ISO13485 in 2003 through the British Standards Institution (BSI). We have also been focusing on establishing an international quality management system, such as by obtaining certifications based on the European Medical Device Directive (93/42/EEC),and the Canadian Medical Devices Conformity Assessment System (CMDCAS). Under our quality policy, we continue to work for quality assurance activities with strict standards, putting effort into the development of products that are trusted by all of our users.

Scope of Certification

The design, development, manufacture, sales, in-house repair, servicing, storage and final staging for distribution of measuring equipment for vital signs and monitoring equipment for vital signs, electrocardiographs, defibrillators, ultrasound imaging systems, oxygen concentrators and associated accessories.

ISO 14001

Fukuda Denshi Shiroi factory have obtained certification of ISO 14001:1996, in June, 2003.We have been performing activities based on ISO 14001 (a recognized international standard that specifies requirements for an environmental management system) as part of the approach to reduce environmental burdens arising from industrial activities and to protect the environment. We will continue to perform environmentally-friendly activities based on our environmental policy.

Green procurement

Fukuda Denshi has established green procurement standards, and with our suppliers, we are working to protect the environment.

Response to the European Union RoHS directive

Some of Fukuda Denshi’s products apply to Category 8 (medical devices) specified in Annex I of the European Union RoHS directive (2011/65/EU).

Fukuda Denshi is moving forward and making every effort for our products to comply with RoHS directive.

Safety and Performance Information

In the following link, there is Safety and Performance Information of Fukuda Denshi products which are exported to EU as per the requirements defied in the Section 23.1 of Annex I of the Medical Device Regulation (EU) 2017/745.

Safety and Performance Information

-This Safety and Performance Information is an extract from Preface and Safety sections of the most recent edition of the Operation Manual  for Fukuda Denshi products exported to the EU.

-Not all Fukuda Denshi products sold in the EU are covered on this page.

-Please refer to the instructions of your Operation Manual or Instruction Manual for more detailed instructions.

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