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美國必達泰克公司（B&W TEK） ?
必達泰克公司（B&W TEK）是一家主營光電產品的高科技公司，集開發、研制、生產于一體，在CCD、PDA、InGaAs、PbS等陣列光譜儀以及拉曼、熒光等光譜系統、高功率半導體激光器等方面均處于世界領先水平。
必達泰克在分子光譜儀器特別是近紅外、拉曼等中高端領域擁有強大的技術實力，儀器各項指標先進，售后及技術服務完善，在廣大客戶群中擁有優秀的聲 譽。值得一提的是，必達泰克公司（B&W TEK）率先在中國市場推出PbS近紅外光譜儀（遠近紅外），率先推出非致冷薄型背照式CCD陣列光譜儀等多款高性價比產品。作為必達泰克公司在中國的全資子公司，必達泰克光電科技致力于為中國客戶提供一流的儀器，一流的服務。?

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.?


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