FAQ
Welcome to our FAQ page. This section covers the most common questions companies ask when engaging Garrett Technologies, Inc. for medical device design and development, consumer product engineering, embedded systems, connected device design, and end-to-end product development—from concept through manufacturing transfer.
What services does Garrett Technologies, Inc. provide?
A: We specialize in medical device product development, electrical engineering, embedded systems, firmware design, PCB layout, DSP algorithms, prototyping, verification, and regulatory-aligned engineering documentation. Our team supports Class I–III devices and complex, safety-critical electronic systems.
Do you work with Class II and Class III medical devices?
A: Yes. We have extensive experience designing Class II and III medical devices, including diagnostics, monitoring systems, implantable support technologies, wearables, wireless medical devices, and combination products. Our processes align with FDA 21 CFR Part 820 and ISO 13485.
Can you help if we already started the design with another firm?
A: Absolutely. We frequently join projects mid-stream to evaluate existing designs, resolve technical issues, refine architecture, complete documentation, or support verification and safety testing.
Do you handle both hardware and firmware development?
A: Yes. Our engineering team provides analog/digital hardware design, mixed-signal circuits, PCB layout, embedded systems, low-level firmware, DSP algorithms, and board bring-up.
Are your engineering processes FDA- and ISO-aligned?
A: Yes. Our work aligns with FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 62304, and IEC 61010. We integrate design controls, risk management, and traceability throughout development.
Can you support verification, validation, and compliance testing?
A: Yes. We support verification planning, execution, and documentation for IEC 60601, 62304, 61010, and related medical standards. We also assist clients preparing for agency testing and regulatory submissions.
What types of medical devices have you worked on?
A: Our experience includes defibrillators, blood glucose systems, diagnostic devices, wearable medical sensors, multiparameter monitoring systems, implantable support technologies, wireless medical devices, and opto-electrical systems.
Do you work with startups or early-stage companies?
A: Yes. Many clients engage us as their primary engineering partner. We help startups define requirements, architecture, risk management, prototyping, and verification planning.
Can you assist with documentation for regulatory submissions?
A: Yes. We create engineering documentation, design history files, requirements, traceability, risk analyses, and verification records that support FDA and international regulatory pathways.
Do you develop custom electronics for medical devices?
A: Yes. We design analog, digital, and mixed-signal circuits, power systems, safety circuitry, sensors, wireless communication modules, and specialized electronic subsystems for medical applications.
Do you support manufacturing transfer?
A: Yes. We prepare design outputs, DFM/DFT updates, test specifications, and transfer documentation. We also collaborate with contract manufacturers to ensure a smooth transition into production.
Do you offer consultations for new medical device concepts?
A: Yes. We provide early-stage technical consultation to help clients assess feasibility, define architecture, identify risks, and plan regulated product development.
Do you work with clients outside the Chicago area?
A: Yes. We support companies across the United States and internationally. Most collaboration can be done remotely, with on-site engagement as needed.
If you have additional questions about medical device engineering or consumer product development, please contact us!
Do you also develop consumer products?
A: Yes. Beyond medical devices, we engineer connected consumer products including appliances, home monitoring systems, sporting-performance electronics, pet-care devices, environmental sensors, IoT devices, and wireless subsystems.