Medical Device Product Development
We take your medical device from concept to certified product.
End-to-end mechanical engineering for medical devices. Design, prototyping, manufacturing, and documentation, all under one roof with regulatory compliance built into every phase.
Concept
Feasibility
Design
Engineering
Prototype
Validation
Production
Tooling
Certified
Compliance
How it works
Five phases. Full traceability.
Each phase produces concrete deliverables you own. No black boxes, no vague timelines. You see exactly what you are getting at every step.
Phase 01
Concept & Feasibility
We evaluate your device concept against clinical requirements, manufacturing constraints, and the regulatory landscape. You get a clear answer on feasibility before committing budget.
Deliverables
Feasibility analysis report
Risk identification matrix
Preliminary design concept
Regulatory pathway recommendation
Project scope and timeline estimate
Phase 02
Design & Engineering
Full mechanical design in SolidWorks with every decision driven by manufacturing and regulatory requirements. No redesign cycles caused by production afterthoughts.
Deliverables
3D CAD models
2D engineering drawings with GD&T
Material selection and biocompatibility justification
Tolerance analysis report
Design for Manufacturing (DFM) optimization report
Bill of Materials (BOM)
Phase 03
Prototyping & Validation
Functional prototypes built and tested against your design inputs. We catch problems in the lab, not in production.
Deliverables
Functional prototypes
Design verification test protocols
Test results and analysis report
Design iteration documentation
Updated CAD models post-testing
Phase 04
Tooling & Manufacturing
From approved design to production parts. We specify tooling, coordinate with qualified manufacturing partners, and inspect every first article.
Deliverables
Tooling specification and quotation package
Manufacturing partner coordination
First-article inspection (FAI) report
Dimensional verification report
Production quality documentation
Finished parts delivered
Phase 05
Documentation & Compliance
A complete documentation package structured for regulatory submission. Design history, verification records, and traceability built in from day one.
Deliverables
Design History File (DHF) structure
Design input/output traceability matrix
Verification and validation summary
Risk management file
Technical documentation package for regulatory submission
Why Leonith
Built for medical device teams.
We are not a general engineering shop that also does medical. Medical device development is our core discipline.
Regulatory-first engineering
Every design decision is made with certification in mind. No surprises at submission time.
Single point of contact
One team from concept to production. No handoff gaps, no lost context between phases.
DFM from day one
We design for the production process, not the prototype. Parts that work in the lab also work on the line.
Complete deliverable package
You own every file, every report, every drawing. Nothing locked behind proprietary formats.
Standards alignment
Designed for compliance.
Our engineering processes and documentation are structured around the standards your regulatory submission depends on.
ISO 13485
Quality Management
ISO 14971
Risk Management
IEC 62304
Software Lifecycle
IEC 60601
Electrical Safety
EU MDR
European Market
FDA 21 CFR 820
US Market
Who this is for
Is this the right fit?
This service is built for teams that need a mechanical engineering partner who understands medical device requirements from day one, not as an add-on.
Start a ConversationMedical device startups developing their first product
Clinical teams with a concept that needs engineering
Established manufacturers expanding their device portfolio
Research groups transitioning from lab to production
Companies that need to outsource mechanical design under regulatory discipline
Ready to develop your medical device?
Start with a structured project intake. Our AI-powered system will assess your project scope and connect you with the right engineering path.