Our services.

 
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PRODUCT DESIGN

  • Concept and prototype development

  • Design iteration, assessment & improvement

  • CAD design & print package creation

  • Material selection

  • In-house rapid prototyping

  • Vast network of service providers

  • User needs, design input, and design output development

  • Design controls execution

 
 
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TEST METHOD VALIDATION

Test Method Creation:

  • Test method design and documentation

  • Equipment design, fabrication , and development

Validation Execution:

  • Traditional gage R&R studies

  • Attribute sampling plan studies

  • Surrogate and standards based studies

  • Inspection reduction rationalizations

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QUALITY & REGULATORY

Quality System Installation & Remediation

  • FDA 21 CFR part 820 & ISO 13485

  • Design controls

  • Risk management (ISO 14971)

  • Supplier assessment & controls

  • Usability (ISO 62366)

Regulatory Testing

  • Design verification (product, packaging, shelf-life)

  • Usability & design validation

 
 
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VALIDATION & SCALE UP

Manufacturing

  • Pilot line creation

  • F/G OEM selection, qualification & management

Process Validation

  • Equipment design, installation & qualification

  • Process development & characterization

  • Operational and process qualification

  • Process verification