COMPANY INFORATION

Company name: Soyama Company Limited - Soyama Co., Ltd
CEO: SOICHIRO YAMADA
CAPITAL: 50,000USD
TAX Code: 3603503489
Company Established: 07 Nov 2017
Address: Street No.1, Agtex IP, Long Binh ward, Bien Hoa city, Dong Nai province, Vietnam

quality & certificate

Soyama Co., Ltd. obtained ISO 13485 certification in 2025, establishing a quality management system compliant with medical device manufacturing requirements.
We have accumulated extensive experience in medical device assembly, with manufacturing processes conducted in controlled cleanroom environments to ensure product quality, safety, and consistency.

VISION &
CORE VALUE

We support long-term and stable partnerships.

COMPANY BOARD

SOICHIRO YAMADA

Serving as a CEO of Soyama Co., Ltd

with over 20 years of experience to operate Medical device manufacturing factory

ACCOMPLISHMENT

Set up Terumo Penpol (India) Company and Factory in 1999 (Employees: 2000) - Led to get ISO 9001, 13485, 3826, 148001
Set up TerumoBCT Vietnam Company and Factory in 2014 (Employees: 1300) - Led to get ISO 9001, 13485, 3826
Establish Soyama Co. Company and Factory in 2017 and led to get ISO13485 in 2025

EXPERIENCE

04/1991 - 1999: Worked in Terumo as quality assurance supervisor for IV solution, Blood Collection Bag, IV and Blood Filter, Apheresis Kit, CAPD

12/1999 - 2012: Participated into India Terumo Penpol Project:

2000 : Manufacturing capacity increased 3 times by investment
2004 : Manufacturing capacity increased 30% more by investment
2008 : Manufacturing capacity increased twice by investment and achieved not more than 1ppm of customer complaint

07/2012 - 2014: Backed to Japan and joined Vietnam New Company and 07/2012 - 2014 Factory Project
05/2014 - 2017 Started to establish & manage Terumo BCT Vietnam as General Manager

03/2015：Obtained ISO 13485
05/2015：Completed building and started validations
08/2015：Started Initial Production of Blood Collection Bag
04/2016：Started Initial production of Apheresis Kit
03/2017：Completed equipment validations & achieved not more than 1 ppm of Blood Collection Bag complaint

03/2018 Established Soyama Co., Ltd as CEO

SKILL

ISO 9001, 13485, 3826, 17665, 11135.
Development, engineering, quality assurance & regulations.
Establishment of a new company and factory in India and Vietnam.
Quality Management System establishment, operation and training.

Training and developing people in India and Vietnam.
Preparation of necessary documentation for contract, export and import of machines, test equipment, materials and packaging.
Design input & output verification, validation document and implementation.

ISO