美国必达泰克公司（B&W TEK）  
必达泰克公司（B&W TEK）是一家主营光电产品的高科技公司，集开发、研制、生产于一体，在CCD、PDA、InGaAs、PbS等阵列光谱仪以及拉曼、荧光等光谱系统、高功率半导体激光器等方面均处于世界领先水平。
必达泰克在分子光谱仪器特别是近红外、拉曼等中高端领域拥有强大的技术实力，仪器各项指标先进，售后及技术服务完善，在广大客户群中拥有优秀的声 誉。值得一提的是，必达泰克公司（B&W TEK）率先在中国市场推出PbS近红外光谱仪（远近红外），率先推出非致冷薄型背照式CCD阵列光谱仪等多款高性价比产品。作为必达泰克公司在中国的全资子公司，必达泰克光电科技致力于为中国客户提供一流的仪器，一流的服务。 

Established in 1997, B&W Tek, Inc. is a Total Solution Provider in design, engineering, prototyping and low cost OEM manufacturing of extensive ranges of bio-medical instruments with emphasis on highly sophisticated bio-photonics instruments, electro-optic instruments and medical lasers. We also offer various associated services in industrial design, custom software development, regulatory compliance testing and certification, and end-user training.
At B&W Tek, we ensure our products and services are in compliance with various government and international standards and we have successfully provided turnkey solutions to many Fortune 100 corporations in different areas. 

CAPABILITIES

Engineering
A research and development team of over 30 engineers all with advanced degrees in multi-discipline areas
Senior leading engineers with over 30 years of industrial experiences
Testing, Certification, and Regulatory compliance
Fast designing and prototyping (usually within 3 months)
Strong vertical integration experiences and capabilities
Extremely flexible and adoptable solutions
Key building blocks: Laser, spectrometers, associated optics & electronics, and IPs


Production
State of the art facilities with ISO 13485 and ISO 2001 certifications
Multi-million dollar manufacturing and test equipment
Combined 30,000 sq.ft. of lab for research, development, customization, and testing
Additional 20,000 sq.ft of modern OEM manufacturing facilities
High quality and low cost manufacturing
Dedicated quality control team


QUALITY CONTROL
At B&W Tek, we assure superior performance, quality, and solid regulatory compliance standards.
With ISO 9001 and 13485 certifications, our facilities are also equipped with a clean room environment which meet the United States requirements.

We are pursuing FDA Quality Systems Inspections Technique (QSIT) approach to conduct Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), and Product Qualifications (PQs) checks as well as software verifications and validations. We also apply Six Sigma methodologies to ensure each product passes all of the tests at each production process level. We also have an extensive and solid final Overall Quality Control Test (OQCT) to make sure our products and services pass or exceed any International standards and regulations.


ISO 9001 / 13485 certified
FDA & CDRH registration and compliance
CE marks and UL marks
Manufacturing FDA Class II and III devices
Application of Six Sigma methodologies approach
Mock FDA Quality Systems Inspections Technique (QSIT).
Extensive Quality Control Check Points including Installation Qualifications (IQs), Operational qualifications (OQs), Performance Qualifications (PQs), and Product Qualifications, as well as software verifications and validations.