New Information
16,April,2018
We will exhibit at Medtec 2018.
Dates: Apr18(Wed)-20(Fri),2018
Venue:TOKYO BIG SIGHT (Booth No.2715)
We are waiting for your visit to the booth.
27,April,2017
We will exhibit at 8th Medical Device Development EXPO (MEDIX).
Dates: June21(Wed)-23(Fri),2017
Venue:TOKYO BIG SIGHT
We are waiting for your visit to the booth.
13,April,2017
We will exhibit at Medtec 2017 from April 19th to 21st.
The place is TOKYO BIG SIGHT.
We are waiting for your visit to the booth.
OEM in Healthcare

By targeting the Japanese market and manufacturing the product in Japan, you will secure high credibility while achieving great savings in cost.
SANYOSEIKO will provide integrated service from manufacturing, procurement, assembly, and quality assurance to packaging!

Healthcare authorization & certification

We will carry out administrative process for your product to be approved by Japan on your behalf!
SANYOSEIKO will assure you to achieve smooth entry into the Japanese market by providing you our experience and know-how from our manufacturing and sales background.

Healthcare Dealership

We will support your company to build best suited sales, repair and service schemes for each medical device by maximizing our many years of experience in the medical equipment industry.

Our Services

SANYOSEIKO adds value to medical equipment by securing safety and improving quality.
A team of experts equipped with industrial knowledge and high level of technology
will partner you in manufacturing phases from development, design, and market entry,
and provide valuable consultation to support your sales on an ongoing basis.
We will be your global business partner by promptly adapting to the ever transforming Japanese market.

OEM in Healthcare

Implementing Unequivocal Quality

For 50 years, SANYOSEIKO has been solving various problems with our customers.
From the very early stages of product design, a select team of experts in the medical field,
engineers and physicians will support your company in clinical and regulatory aspects,
and will serve to provide high credibility and added-value to your product
by assisting through the entire lifecycle of medical equipment products.


Optical prism – clearance angle 0.0083° Material: Super Invar (low expansion alloy)
3-D measurement device - nucleus part; clearance angle and parallel plane clearance level within 0.01
Performance tester of electronic parts and ranking device “Handler” Assy

Business Results in Japan

We have delivered our services
in the following industries and fields

Healthcare Equipment

Medical analysis device, measuring device,
research device for innovative drug development,
implantation
anesthesiology, neurosurgery, pain clinics,
orthopedic, internal medicine, cardiology.

Industrial Equipment

optics, precision measurement, analytical instrument,
semiconductor production, robotics,
industrial machines, automobile and aerospace

High temperature observation equipment “SMT Scope” series
Heating chamber and observation unit
of SMT Scope
Displacement detector and wettability testing apparatus, “SDM-4000”
Relay lens unit for light condensing
Excimer laser processing machines
Cardio Vision MS-2000
for assessment of arterial aging
Pain Vision PS-2100
for numeration and assessment of pain
Dental Implant

Healthcare authorization & certification

Establishment of management system with a focus on
quality control and reliability for medical equipment

Strict adherence to various regulations and standards
issued by different countries is required in the medical equipment industry.
The guidance instituted by the regulations are complex
and require full knowledge and experience in the market.
With our team of experts, SANYOSEIKO will follow market trends diligently
and provide environment for quality management.

We are constantly updating our knowledge on latest technology and knowledge
regarding designing and production of medical equipment assured with high standard of safety
and effectiveness based on cutting edge technology and scientific research
while applying strict standards upon medical related products.
Our certification for your quality assurance is a proof of strict adherence
to global standards, such as ISO13485 certification.
It will be a proof that your products are manufactured under certified quality management system.

  • Certification of Medical equipment under PMD Act
  • Establishment of quality management system for medical equipment:
    ISO13485, QMS Ordinance, QSR(21CFR Part820)
  • Establishment of risk management system for medical equipment ISO14971
  • Establishment of medical equipment software lifecycle: IEC62304
  • Establishment of usability for medical equipment: IEC62366
  • Fundamental safety for ME apparatus: IEC60601-1 (Third edition)
  • Approved by new JIS standards!
    JIS Z 3284-4 4.5 displacement detector and wettability testing (solder paste)
    JEITA ETX-7412 Displacement method (micro-surface packaging part)

Healthcare Dealership

Secure your Japanese market success

There is a big burden in finding Distributors when entering the Japanese market.
We will manufacture and assemble your medical devices
on your behalf in Japan, and if you already have a distributor,
we will deliver the product and solve technical problems when malfunction occurs.

Unlike conventional schemes, it would be unnecessary
for shipping back non-conforming products to your country
and you will also reduce the number of trips for sending your engineers to Japan.
By providing our logistic service for your products, you can reduce the total cost of a product.

When searching for a distributor, you must begin with Japan’s market research
and also perform due diligence on potential partners,
and as a certified manufacturer and seller in Japan,
Sanyo Seiko will provide you a comprehensive support until
the actual signing of a contract with the best suited distributor.
If necessary, we will be your distributor in Japan and sell your products on your behalf.

Moreover, if you already have a sales rep in place but are having difficulties
in providing maintenance and overhaul services,
we will provide the solution you have been seeking.
SANYOSEIKO will provide maintenance, overhaul and routine check-up duties in Japan
on your behalf for medical equipment that you have delivered to Japan.
With our dedicated service, you will be able to maintain your hard gained creditability
and provide security and safety to the users.

Corporate Info

Business Overview

Production Division

Machining : compound/optics/micro/3D/thin/complex cutting/high precision cutting processing

Design and Assembly : mechanics/optics/electronics/imaging/designing and assembly of machines

Element technology : optical, vacuum, temperature and medical equipment

Medical Equipment Division

R&D, Manufacturing and Sales of pain assessment device, “PainVision”
& Arterial stiffness assessment device “CardioVision”.

Production Synthesis Network “Manufacturing Support Corps”

We manufacture products in collaboration with over 100 partner companies.
We will accept orders for metal sheets, plastics and finishing and many others.

SMT Division

R&D, Manufacturing and Sales of high temperature observation system “SMT Scope”
and displacement detector and wettability testing apparatus, “SDM-4000”.

History

1963
Established SANYOSEIKO Co., Ltd.
1998
Developed original high temperature observation product
2000
Inaugurated of Tokyo office (R&D HQ, current SMT Division)
2003
Certified by ISO9001
2007
Inaugurated Production Synthesis Network “Manufacturing Support Corps”
2010
Certified by ISO14001
2013
Strategic business collaboration with Osachi Co., Ltd. a medical equipment maker
2014
Certified as a “manufacturer of medical equipment”
Established Ukita Shirakawa Medical Design & Consultation Co., Ltd.
Japan’s first independent medical design company
Participate in standardization of JIS “Solder paste-Part4:Test methods for wettability,solderball and spread”
2015
Certified by ISO13485 & Type 2 medical equipment marketing authorization holder

Awards

2006
“300 Productive SMEs of Japan” Award
2008
CEO & President Juichi Shirakawa received Order of the Rising Sun
2009
Yamanashi Industrial Award Grand Prize
2012
Yamanashi Industrial Award Management Quality Division
2014
JPCA Award (Japan Electronics Packaging Circuits Association)

Business Locations

Sanyo Seiko Co., Ltd. HQ and Main Factory
1435 Ozawa, Saruhashi-machi, Otsuki City, Yamanashi 409-0616 JAPAN

Ozawa Factory
789 Ozawa, Saruhashi-machi, Otsuki City, Yamanashi 409-0616 JAPAN

Medical Device Factory, Shimowada
1150, Shimowada, Nanaho-machi Otsuiki-shi, Yamanashi 409-0622, JAPAN

Nagano Factory
2-9-11 Osachikohagi, Okaya City, Nagano 394-0085 JAPAN

Tokyo Sales Office
3F da Vinci Bldg. 7-6 Higashi-machi, Hachioji City, Tokyo 192-0082 JAPAN

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