Biomedical Engineering & Medical Devices
FUEL’s biomedical team builds your device to the standards needed to launch a clinical trial. We take a radical napkin-sketch idea and turn it into a working device, starting from the big-picture view and working incrementally to something that performs in the field, meets regulatory and engineering requirements for safety and function, and makes life better for the people who use it. We do the important work to satisfy the requirements without burying the path to product in needless bureaucracy.
What we design
Devices we develop
We develop medical and health devices across diagnostics, monitoring, and rehabilitation, typically in batches of 5 to 100 units, and take on the whole build rather than a slice of it.
- Diagnostic instruments and electromechanical devices
- Wearables and health monitoring, including blood pressure and heart rate devices
- Clinical-trial devices
- Surgical training simulators and haptic devices
- Outpatient, rehabilitation, accessibility, and adaptability devices
Design controls & regulatory
Medical device development lives or dies on its records. We manage the design controls and documentation that carry a device into a clinical trial.
- Design controls and the Design History File, with all design inputs and outputs
- Risk management to ISO 14971
- Usability and human factors to IEC 62366
- Device software to IEC 62304
- Verification and validation, plus biocompatibility and sterilization strategy
- Regulatory strategy for FDA 510(k), Health Canada, and EU MDR
Chemistry-informed device design
Diagnostic and clinical devices succeed only when the chemistry inside them is designed for, not around. Our chemists and biochemists work alongside the biomedical, electrical, and mechanical teams, so material compatibility, reagent handling, sample integrity, and assay performance are engineered into the device from the start.
- Biocompatibility and materials to the ISO 10993 series
- Reagent handling, fluidic paths, and contamination control
- Assay integration and sample-preparation workflows
- Design for reagent stability and shelf life
Tools, standards & methods
We design in Onshape for 3D CAD and analyze in SimScale for FEA and CFD, with design control through our in-house quality management system. Before handoff we run functional validation of hardware and software, electrical tests, functional software testing, and pump and fluidics testing to confirm the device meets its original functional requirements. Validation that needs interaction with users or patients is done in collaboration with clinical advisors at a hospital or care facility. Emissions and specialized environmental testing are done at outside labs.
We design to the medical device standards each project requires. These are design targets, not certifications, and the ISO 9001 / ISO 13485 quality system is at the pre-audit stage:
- Quality system and regulatory: developed under a quality management system pursuing dual ISO 9001 / ISO 13485 certification, currently at the pre-audit stage, plus FDA 21 CFR 820, MDSAP, Health Canada MDL and MDEL, FDA 510(k), and EU MDR and IVDR
- Risk, usability, and software: ISO 14971, IEC 62366-1, and IEC 62304
- Device safety and EMC: IEC 60601-1, 60601-1-2, 60601-1-11, and the 60601-2 device-specific series
- Biocompatibility and sterilization: the ISO 10993 series, USP Class VI, and ISO 11135, 11137, and 17665
- Clinical: ISO 14155 and Good Clinical Practice
Where it fits in our process
A generic product shop can build hardware. FUEL brings deep medical science together with real product development: a team led by a biomedical engineer with 25 years in the field, with biomedical graduates, electrical and software engineers, and biochemistry scientists all working under one ISO 9001 / ISO 13485 design-control process. We do not want to stop at handing over a drawing package. We build, validate, and send the device out into the world, then stay with you to support it in the market, troubleshooting and folding user feedback back into the design. See how we work for the full path from concept to production.
Frequently asked questions
Can you take a medical device from concept to a clinical trial?
Yes. We build your device to the standards needed to launch a clinical trial, managing the Design History File with all design inputs and outputs, verification and validation, risk analysis, and the regulatory documents required.
Do you work under a medical device quality system?
Yes. Our work is developed under a quality management system pursuing dual ISO 9001 / ISO 13485 certification, currently at the pre-audit stage, and we apply it to every project, not just medical devices.
Do you build the devices, or just design them?
We build them. We take devices beyond a prototype into pre-production and production runs, typically batches of 5 to 100 units, and support them in the field after launch.
What kinds of medical devices do you develop?
Diagnostic instruments, wearables and health monitors, clinical-trial devices, surgical training simulators, haptic and outpatient devices, and rehabilitation and accessibility devices.
Do you handle risk management, usability, and verification and validation?
Yes. We design to ISO 14971 for risk management, IEC 62366 for usability, and IEC 62304 for device software, and we validate hardware and software function in-house before handoff.
Are your devices FDA or Health Canada approved?
Approval is device-by-device, not a blanket status any development firm holds. We design to FDA 21 CFR 820, Health Canada, EU MDR, and IEC 60601 requirements so your device is ready for the clearances its market requires.