Our Services
Our technical knowledge, expertise and problem solving skills provide cost-effective solutions to our clients' most pressing challenges and problems.

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Medical Device Design

•  Brainstorming for new ideas and intellectual property generation

•  Prototyping and design iteration

•  Independent design review

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Biomaterials Sourcing

•  Optimized biomaterials selection based on application

•  Identification and selection of critical material suppliers (ePTFE, etc.)

•  Material characterization, testing and specification setting

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Test Method Validation

•  Test method development or improvement

•  Equipment design, vendor selection and equipment procurement

•  Validation protocol development and execution (Gauge R&R)

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Process Validation

•  Process development or improvement

•  Equipment design, vendor selection and equipment procurement

•  Validation protocol development and execution (IQ/OQ/PQ)

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Regulatory Submission

•  Biocompatibility test report

•  Supporting documents for U.S. submission (510(k), PMA, etc.)

•  Supporting documents for international submission (EU, China, etc.)

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Technology Transfer

•  Scouting new technology for business development

•  Due diligence of new technology

•  Management of technology transfer