Turning Ideas into Market-Ready Medical Devices​

Bringing a medical device from concept to market requires precise execution, regulatory expertise, and proactive risk management. At SQR-1 Engineering, we help companies navigate these challenges with structured, efficient, and compliant project execution strategies that drive success.

Our Approach to Project Execution

1. Create Clear Project Milestones

We collaborate with clients to define clear milestones and timelines from the start, ensuring transparency and alignment at every stage.
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2. Regulatory-First Execution

We prioritize compliance with FDA, ISO 13485, and MDR standards, integrating regulatory requirements early to avoid delays.

3. Cross-Functional Collaboration

​Engineering, quality, and manufacturing teams work seamlessly together, ensuring smooth transitions and efficient project execution.

4. Risk Management & Mitigation

​We proactively identify and manage risks, implementing mitigation strategies to prevent setbacks before they arise.

5. Scalable & Efficient Execution

Our approach is adaptable to projects of any size, delivering efficient solutions without sacrificing quality.

Project Success Profile

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
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line

Support for Medical Device Development​

We offer support projects in a variety of medical device disciplines, including R&D, RAQA, and Manufacturing Engineering.  Click the icons below to learn how we engage in each phase.

Medical Device Expertise

Project Expertise