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A company is best judged by its results. Below you will find links to a number of case studies that are representative of the work done by our consultants...

Product Development

Cardiac Implant Concept PhaseFunctional PrototypingMechanical Assy Cost Reduction

 

Design Control

Complete Design Control SystemDesign Control-Regulatory Response
Design Control TemplatesDesign Control Training

Approach to Development Planning

Implant RequirementsDispoasbles Requirements
Software RequirementsRapid Requirements Review

Software Design Verification

Risk Analysis-Life Support System

 

Quality Assurance

Foreign Plant QSR Gap AnalysisForeign Mfg Plant CAPA SystemImproved Risk Management SOP

 

Regulatory Affairs

483 on MDR Reporting
510(k) - Life Support SystemOpthalmic Surgical Device 510(k)

 

Manufacturing

 

Mechanical Assy Cost ReductionPlant-wide Validation ReviewTest Method Validation

 

Project Management

Management of Stalled Project

 

Opportunity Identification

Case studies will be available shortly, check back soon.

 

Opportunity Assessment

Due Diligence Support

 

Planning

 

Timeline DevelopmentWork Breakdown Structure

 

Execution

 

Case studies will be available shortly, check back soon.

 

Expert Witness

Expert Witness

 

 

 

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