COMPANY DESCRIPTION
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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.
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| CAPABILITIES |
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| 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
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| 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
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| 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.
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- 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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| Delivery and Shipping |
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