Downright Logical
Consultancy focused on end-to-end medical device product development and regulatory support. Services cover market definition, requirements engineering, systems engineering, detailed design, verification and validation, risk management, project management, and preparation of regulatory submission packages for US and European markets. Operates with a phase-gate product development approach and reports multi-decade experience in medical device development.
Industries
Downright Logical
Orlando, Florida, United States, North America
Services
Medical device design and development
End-to-end device design services from requirements definition through detailed design and verification.
Systems engineering
Architecture, system partitioning, and operational flow design with integrated risk management.
Project management
Project and program management to meet cost, schedule, and performance targets.
Market analysis and IP evaluation
Market definition and intellectual property landscape analysis to inform product requirements and strategy.
Verification and validation
Design verification testing and validation planning to generate evidence for regulatory submissions.
Regulatory compliance support
Support for compiling documentation and navigating regulatory pathways for US and European market entry.
Medical device design and development
End-to-end device design services from requirements definition through detailed design and verification.
Systems engineering
Architecture, system partitioning, and operational flow design with integrated risk management.
Project management
Project and program management to meet cost, schedule, and performance targets.
Market analysis and IP evaluation
Market definition and intellectual property landscape analysis to inform product requirements and strategy.
Verification and validation
Design verification testing and validation planning to generate evidence for regulatory submissions.
Regulatory compliance support
Support for compiling documentation and navigating regulatory pathways for US and European market entry.
Expertise Areas
- Medical device product development
- Systems engineering
- Regulatory submissions (US and EU)
- Design verification and validation
Key Technologies
- Phase-gate development process
- Systems engineering methodologies
- Requirements engineering
- Design verification and validation