What we do
Based in Long Beach, CA. Serving clients across Southern California and beyond.
Design Review & Feasibility
We audit what you've already built, or run a short sprint to prove the riskiest bet before you commit real budget.
Product Development
Hardware, firmware, prototypes, records and manufacturing files, one controlled build. Works the same whether you're starting clean or recovering a stalled design.
Team Augmentation
Add senior engineering capacity without the normal recruiting delay. Your tools, your workflow, no ramp-up time.
What we own. What stays yours.
Medical device PCB design and firmware. You own the regulatory relationship, we own the engineering.
- Hardware and firmware program ownership
- Engineering requirements and architecture
- Design rationale and review records
- Risk-control implementation evidence
- Pre-compliance testing and remediation
- Manufacturing files and transfer documentation
- Intended use and clinical claims
- Regulatory pathway and submission ownership
- Product-level risk acceptance and final approval
- Supplier qualification and oversight
We generate engineering records as we work. We coordinate with your quality and regulatory team and run practical pre-compliance evaluation within the agreed scope. Your team retains responsibility for intended use, regulatory strategy, supplier oversight and final approval. We never author or submit on your behalf. Pursuing ISO 9001 and ISO 13485 quality-system certification.
See the ultrasound positioning controllerTransparent pricing
We scope and quote every project upfront. You know the price before we start. Team Augmentation is billed hourly.