Seasoned pros with 100+ years of end-to-end product development expertise.
HELPING AMERICA REGAIN THE ADVANTAGE.
For too long, American companies have been teaching other countries how to manufacture PPE–just to export it back to us. The pandemic exposed fatal flaws in that approach. It made our healthcare system vulnerable.
That's why we channel our energies into a mission-critical, US-centric capability.
HOW WE WORK.
Learn your vision. Strategize together. Stay on the field to help execute.
We become embedded into your team and don’t quit until the job is done.
WHAT WE DO.
Product Definition
The preparation of design criteria:
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Use-Case Scenarios
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Regulatory Assessment
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Intellectual Property Strategy
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Stakeholder Requirements
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Claims Matrix
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Pattern Designs
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Project Timeline with Deliverables
Feasibility Studies
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Product Safety Assessment
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Risk Assessment
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Design Input Documentation
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Sourcing Material / Selection
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Materials Sourcing / Selection Matrix
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Design and Development
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Verification and Validation Plan
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Documented a Matrix and Test Plan
Validation and Transfer
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Sterilization Validation
(if required)
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Compilation of Verification Including:
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Product Specifications
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Test Results
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Drawings
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Packaging and Labeling
Post Launch
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Transfer of All Design Control Documents
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Intellectual Property Including White Paper, Patent Applications, Technical Data Sheets
