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MedTech Consulting: Your Partner in Progress

We help medical device teams move smarter and faster—without sacrificing quality. Whether you're building your first product or scaling globally, SQR1 delivers the strategic and technical support to get you there.
6 Morgan, Ste 125, Irvine, CA 92618
Our Services
  • Product Development
  • Quality Engineering
  • Regulatory & Compliance
  • Manufacturing
  • Strategy

​Product Development

​From early concept through commercialization, we support every stage of the product lifecycle. Our engineers balance speed and precision to guide design, risk management, usability, and documentation.

Quality Engineering

Strong quality systems create stronger outcomes. We help build and optimize QMS, support audits and remediation, and drive risk-based improvements to ensure compliance and durability in design.

Regulatory & Compliance

​We help clients align to regulatory frameworks: FDA, EU MDR, ISO, and more. Our clients are prepared for submissions, audits, and market entry.

Manufacturing

​Designing for scale is a challenge. We help clients avoid costly delays and ensure their product is built right. We offer support for DFM, process optimization, and validation (IQOQPQ).

Strategy

​​Sometimes you need more than extra hands—you need clarity. We partner with leadership to assess technical gaps, guide hiring decisions, and build scalable systems that support long-term growth.

Explore Our Case Studies

See how we've helped MedTech companies overcome design challenges, navigate compliance, and bring life-changing devices to market.​

Hands-On Subject Matter Experts

At SQR1 Engineering, we do more than advise—we execute. Our consulting services help clients stay ahead of their workload while tackling critical challenges. We operate as hands-on subject matter experts, actively driving projects forward, while also providing senior-level advisory support.
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Whether it’s a quick-turn project or a multi-year initiative, our team is ready to deliver the expertise and execution you need.

Our ​Project Success Path

In the dynamic world of MedTech engineering, our clients present us with a wide range of challenges. That’s why we take the time to listen—understanding the specific needs, constraints, and goals of each project. With this foundation, we tailor our approach to align with project objectives, ensuring precision, efficiency, and successful outcomes. The diagram below illustrates our project success path.
Learn About Project Execution
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1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line
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