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)
Services
Systems, mechanical, electrical and software engineering support across concept, design, prototyping and transfer to manufacturing.
Dedicated project management, change control, milestone planning, and risk tracking tailored for regulated medical device projects.
Regulatory pathway selection, preparation of submission documentation, quality system alignment, and audit preparation for FDA, EU and global markets.
V&V planning and execution including software quality, electrical safety testing, usability studies, and evidence generation for regulatory filings.
Additive manufacturing (FDM, SLA), desktop injection molding and post-processing to accelerate development and usability testing.
Low-volume production runs and pilot builds suitable for market entry and verification/validation builds, with tooling strategies to reduce NRE.
Systems, mechanical, electrical and software engineering support across concept, design, prototyping and transfer to manufacturing.
Dedicated project management, change control, milestone planning, and risk tracking tailored for regulated medical device projects.
Regulatory pathway selection, preparation of submission documentation, quality system alignment, and audit preparation for FDA, EU and global markets.
V&V planning and execution including software quality, electrical safety testing, usability studies, and evidence generation for regulatory filings.
Additive manufacturing (FDM, SLA), desktop injection molding and post-processing to accelerate development and usability testing.
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
News & Updates
Blog on applying ISO 14971 and data-driven risk management to speed development and reduce costly redesigns.
Article describing project-structure causes of missed milestones and the role of dedicated project management.
Discussion of small-batch manufacturing use cases, pilot runs, and strategies for low-volume regulated production.
Guidance on prioritizing and structuring documentation (QMS mapping, SOPs, design controls, risk files, traceability) to increase investor confidence and reduce perceived regulatory risk.
Analysis of Florida's MedTech manufacturing ecosystem, regional hubs, and state-level incentives relevant to companies evaluating manufacturing expansion.
Advice on early engagement with manufacturing partners to avoid late-stage redesigns, reduce costs, and protect timelines.
Blog on applying ISO 14971 and data-driven risk management to speed development and reduce costly redesigns.
Article describing project-structure causes of missed milestones and the role of dedicated project management.
Discussion of small-batch manufacturing use cases, pilot runs, and strategies for low-volume regulated production.
Guidance on prioritizing and structuring documentation (QMS mapping, SOPs, design controls, risk files, traceability) to increase investor confidence and reduce perceived regulatory risk.
Analysis of Florida's MedTech manufacturing ecosystem, regional hubs, and state-level incentives relevant to companies evaluating manufacturing expansion.
Advice on early engagement with manufacturing partners to avoid late-stage redesigns, reduce costs, and protect timelines.