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
Nr. of Employees
small (1-50)
Downright Logical
2748 Rivers End Rd, Orlando, Florida 32817
Services
End-to-end device design services from requirements definition through detailed design and verification.
Architecture, system partitioning, and operational flow design with integrated risk management.
Project and program management to meet cost, schedule, and performance targets.
Market definition and intellectual property landscape analysis to inform product requirements and strategy.
Design verification testing and validation planning to generate evidence for regulatory submissions.
Support for compiling documentation and navigating regulatory pathways for US and European market entry.
End-to-end device design services from requirements definition through detailed design and verification.
Architecture, system partitioning, and operational flow design with integrated risk management.
Project and program management to meet cost, schedule, and performance targets.
Market definition and intellectual property landscape analysis to inform product requirements and strategy.
Design verification testing and validation planning to generate evidence for regulatory submissions.
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
News & Updates
The firm reports over 20 years of experience developing medical devices across diagnostic, therapeutic, capital equipment, disposables, and drug/device combinations.
Reported involvement in 15 market introductions.
Reported involvement in 10 successful FDA approvals (examples listed: 510(k), PMA).
The firm reports over 20 years of experience developing medical devices across diagnostic, therapeutic, capital equipment, disposables, and drug/device combinations.
Reported involvement in 15 market introductions.
Reported involvement in 10 successful FDA approvals (examples listed: 510(k), PMA).