Medical Device Design Engineering Consulting Programs

Specific Programs:

• Independent Project Assessment
• Planning and Strategy for International Projects
• Independent Assessment of Project Software Aspects
• Corrective Action Techniques for Software Projects
• Safety Design Strategy (e.g. Medical Devices)
• Systems Engineering Strategy
• Onsite Instruction for Compliant Medical Device Development
  
  » Design Control for Medical Device Professionals
  » Software Development Requirements for Medical Devices
• Independent Decision Recommendations for Projects Examples: Major Project Decisions, including Reorganization, Safety Rationale/Analysis (e.g. Medical Devices), Selection of Software Operating Systems, Software Development Environment, Project/Development Tools, Project Standards, Selection of Specific Components

Our Programs Share the Following Characteristics

• We utilize state of the art industry recognized techniques
• Standards are employed whenever possible
• Programs are conducted by personnel with hands-on experience
• We will customize the program for your specific needs

Example: Standard Outline for Independent Project Assessment

• Review of Planned Project Process
• Status vs. Plan
• Review of Project in terms of managing the following:
  
  » Project Integration
  » Scope
  » Quality
  » Time
  » Cost
  » Risk
  » HR
  » Procurement
  » Communications
  
• Particular Considerations for International Aspects (if applicable)
• Recommendations