FDA & EU Regulated Expertise

• Design Input Development
• Requirements Management and Traceability
• Risk Management
• Design Controls
• Product Characterization
• Product Verification and Validation
• Process and Component Specification Development
• DHR Development
• Design of Experiments (DOE)
• Statistical Analysis
• Tolerance Analysis
• Capability Analysis
• Process Validation

FDA & EU Regulated Engagements

Product Design Requirement Development Projects:  Developed complete and traceable product design input requirement sets, taking high level user needs and translating them into measureable and testable requirements for blood glucose monitoring systems and patient controlled analgesia drug-device combination products.

Risk Management Project:  Developed and implemented comprehensive product risk management solutions that provided summarized risk ranking at the product level based on multi-level risk assessment for patient controlled analgesia drug-device combination products.  These systems employed a consistent hazard ranking approach, from the top product level through to manufacturing processes and raw materials. 

Product Design Characterization Projects:  Worked with product development teams to plan and execute comprehensive product design analysis efforts to clarify the effects design characteristics have on product design input requirements.  This resulted in the development of robust design and process specifications for patient controlled analgesia and drug eluting coronary stent drug-device combination products.

Product Design Verification Projects:  Worked with product development teams to plan and execute comprehensive product design verification testing to demonstrate the product met all design input requirements for blood glucose monitoring systems and patient controlled analgesia drug-device combination products.