Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
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Serving the MedTech Industry

​Engineering Solutions for Every Stage of Medical Device Development
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Our Services

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MedTech Consulting

​Our experienced engineers are your guides in all things MedTech. We'll help ensure compliance with FDA and ISO regulations, support design projects, and streamline manufacturing processes.
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CAD Development & Documentation

We support robust CAD development to ensure design accuracy, traceability, and full alignment with regulatory standards at every stage.
CAD Capabilities
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Technical Training

​Staying competitive in MedTech means staying current. Our subject matter experts deliver targeted training to keep your team sharp, compliant, and confident.
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How we can help.

At Square-1 Engineering, our services are designed to support every phase of medical device development. Our engineering team specializes in Research & Development, Regulatory Affairs & Quality Assurance, and Manufacturing Engineering.
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Whether you're designing a new product, refining your documentation, or training your staff, our team brings industry expertise to every engagement. With 10 years operating exclusively within the MedTech industry, SQR1 is well-positioned to help navigate regulations, develop strategy, and race against competition.
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Explore Our Case Studies

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

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.
Learn About Project Execution
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1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line

White Papers &​ Articles

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The History of Southern California Medical Device
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Site ​Navigation

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  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers >
      • Careers - Marketing Generalist
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers >
      • Careers - Marketing Generalist
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us