MedTech Consulting: Your Partner in ProgressWe 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.
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Our consulting services:
Product DevelopmentFrom 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.
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Quality EngineeringStrong 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.
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Regulatory & ComplianceWe help clients align to regulatory frameworks: FDA, EU MDR, ISO, and more. Our clients are prepared for submissions, audits, and market entry.
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ManufacturingDesigning 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).
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StrategySometimes 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.
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Hands-On SMEsAt 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.
Whether it’s a quick-turn project or a multi-year initiative, our team is ready to deliver the expertise and execution you need. |
Explore Our Case StudiesSee how we've helped MedTech companies overcome design challenges, navigate compliance, and bring life-changing devices to market.
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The 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.
1. Discovery
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2. Project Planning
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3. Deployment
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4. Quality Assurance
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5. Finish Line
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White Papers & Articles |
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