Concise Engineering
Consultancy providing engineering and regulatory support for medical device development. Services span concept, rapid prototyping, design for manufacturability, verification & validation, regulatory strategy and submissions, small-batch and pilot manufacturing, supply-chain planning, usability testing, and project and risk management. Also offers investor-focused documentation support and manufacturing location/incentives assessment.
Industries
Nr. of Employees
small (1-50)
Concise Engineering
Clearwater, Florida, United States, North America
Services
End-to-end medical device engineering
Systems, mechanical, electrical and software engineering support across concept, design, prototyping and transfer to manufacturing.
Project and risk management for MedTech
Dedicated project management, change control, milestone planning, and risk tracking tailored for regulated medical device projects.
Regulatory strategy and submission support
Regulatory pathway selection, preparation of submission documentation, quality system alignment, and audit preparation for FDA, EU and global markets.
Verification, validation and usability testing
V&V planning and execution including software quality, electrical safety testing, usability studies, and evidence generation for regulatory filings.
Rapid prototyping and design iteration
Additive manufacturing (FDM, SLA), desktop injection molding and post-processing to accelerate development and usability testing.
Small-batch and pilot manufacturing
Low-volume production runs and pilot builds suitable for market entry and verification/validation builds, with tooling strategies to reduce NRE.
End-to-end medical device engineering
Systems, mechanical, electrical and software engineering support across concept, design, prototyping and transfer to manufacturing.
Project and risk management for MedTech
Dedicated project management, change control, milestone planning, and risk tracking tailored for regulated medical device projects.
Regulatory strategy and submission support
Regulatory pathway selection, preparation of submission documentation, quality system alignment, and audit preparation for FDA, EU and global markets.
Verification, validation and usability testing
V&V planning and execution including software quality, electrical safety testing, usability studies, and evidence generation for regulatory filings.
Rapid prototyping and design iteration
Additive manufacturing (FDM, SLA), desktop injection molding and post-processing to accelerate development and usability testing.
Small-batch and pilot manufacturing
Low-volume production runs and pilot builds suitable for market entry and verification/validation builds, with tooling strategies to reduce NRE.
Expertise Areas
- Medical device design and development
- Regulatory strategy and compliance (FDA, EU MDR)
- Risk management and ISO 14971 implementation
- Verification & validation, process validation and usability engineering
Key Technologies
- Fused deposition modeling (FDM) 3D printing
- Stereolithography (SLA) 3D printing
- Desktop injection molding
- Quick-turn prototyping workflows