Defined-scope projects
A fixed deliverable with a clear scope — for example a risk management file, a V&V protocol set or a DHF gap assessment.
Services
Medical device engineering services
Specialized support across the full design control lifecycle — from defining user needs to releasing a validated design to manufacturing.
Product Design & Development
We turn clinical needs into buildable, testable designs — defining user needs, translating them into measurable design inputs, and engineering the mechanical, electrical and material solutions that meet them.
- User needs & design input definition
- Concept generation and feasibility studies
- Mechanical design & 3D CAD
- Material and biocompatibility considerations (ISO 10993)
- Rapid prototyping & bench evaluation
- Tolerance analysis and design reviews
Design Controls & DHF
Good engineering must also be well documented. We set up or remediate design control processes so every requirement traces to a verified output — and your design history file tells a clear, defensible story.
- Design & development planning
- Requirements and traceability matrices
- Design History File (DHF) creation & remediation
- Formal design review facilitation
- Design change control
- Gap assessments against ISO 13485 §7.3
Risk Management
We integrate risk management into the engineering process from day one, so hazards are identified early and mitigations are designed in rather than bolted on.
- Risk management plans & reports
- Hazard analysis and PHA
- Design and process FMEA (dFMEA / pFMEA)
- Fault tree analysis
- Risk control verification
- Benefit-risk and residual risk evaluation
Verification & Validation
We plan and execute V&V programs that generate objective evidence — statistically justified, clearly documented and aligned with recognized consensus standards.
- V&V master plans and test strategy
- Protocol and report authoring
- Statistical sample size rationale
- IEC 60601 electrical safety & EMC test readiness
- Usability engineering (IEC 62366-1)
- Test lab selection and management
Software & Electronics
Connected and software-driven devices bring their own lifecycle requirements. We help teams build electronics and software that are safe, maintainable and ready for review.
- IEC 62304 software lifecycle processes
- Software safety classification
- Embedded architecture & hardware design review
- Software requirements and unit/integration testing
- Cybersecurity risk considerations
- SOUP / OTS component management
Design Transfer & Manufacturing
A design is only successful when it can be built reliably. We prepare your product and your suppliers for production with robust documentation and validated processes.
- Design for manufacturability (DFM/DFA)
- Device Master Record (DMR) preparation
- Process validation (IQ / OQ / PQ)
- Supplier qualification support
- Test method validation
- Pilot build and scale-up support
Engagement models
Work with us the way that fits your project
Phase-based programs
We lead or support one or more development phases, with agreed milestones and design review gates.
Embedded engineering
Ongoing, flexible capacity that works inside your team, tools and quality system.
FAQ
Common questions
Can you work within our existing quality management system?
Yes. We adapt to your procedures, templates and document control system. If you don't yet have a QMS, we can help you establish right-sized design control procedures for your stage.
Do you only support new product development?
No. We also support sustaining engineering, design changes to marketed devices, DHF and risk file remediation, and preparation for audits.
What types of devices do you support?
We support a range of device types, including electromechanical, powered, software-driven, wearable and single-use devices. Contact us to discuss whether your project is a good fit.
How do engagements start?
With a no-obligation conversation about your device, your current stage and your goals. We then propose a scope, timeline and engagement model that fits.
Will you sign a non-disclosure agreement?
Yes. We routinely execute NDAs before detailed technical discussions.
Have a device concept or a design challenge?
Tell us where your project stands. We'll reply with practical next steps — no obligation.