Great Processes, Great Results

Bringing a medical device from concept to market requires precise execution, regulatory expertise, and proactive risk management. At SQR1 Engineering, we help companies navigate these challenges with structured, efficient, and compliant project execution strategies that drive success.

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

Our Approach to Project Execution

1. Discovery

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. Project Planning

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

3. Deployment

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

4. Quality Assurance

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

5. Finish Line

Every project closes with a thorough review to ensure quality standards are met across the board. With clean handoffs, final documentation and proper training, your team is set up for success.

Support for Medical Device Development​

We provide support for medical device needs in R&D, RAQA, and Manufacturing Engineering. Click the icons below to learn more.