Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA

The Medtech Problem Solvers

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Your Partners in MedTech

Your technology is unique, which is why it's time you partnered with a firm who understands your technology AND utilizes unique solutions to help you get ahead!

At Square-1 Engineering, we provide technical consulting services across the entire medical device product life cycle from product ideation to obsolescence.  Our skilled engineering and compliance teams take on projects of all sizes in R&D Engineering, Quality & Compliance, Regulatory (RAQA) and Manufacturing Engineering.​
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How we can help:

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MedTech Consulting
Experts in Class II & III ​R&D, RAQA & Mfg Engineering
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CAD Services
Mechanical & Electrical Design, Drafting & cGMP Documentation
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Technical Training
Whether it's Regulations, Compliance, or CAD: we help you grow.
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Why clients rely on us:

Subject Matter Experts
  • Loss of key personnel
  • M&A due diligence
  • Audit Preparedness
  • ​Advisory & Validation
  • Marketplace Insights
Critical Events
  • Milestone attainment
  • Regulatory events (remediation, submission)
  • Changes in supply chain
  • ​Lay offs
Limited Bandwidth
  • Significant growth
  • New funding
  • M&A integration
  • Facility transfers
  • ​Balancing NPD vs Sustaining Activities
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​They Said It Best 

Our results speak for themselves—and so do our clients. Here’s what they’re saying about working with the SQR1 team. Slide through a few highlights from people with firsthand experience.
Reviews

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.
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Case Studies

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Medical Device Expertise

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Project Expertise

About ​Square-1 Engineering

Bringing a medical device to market is complex—and the right expertise makes all the difference. Whether it’s navigating approvals, untangling remediation, supporting CAD design, or streamlining manufacturing, we guide our clients with clarity and confidence.
About Us
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The MedTech Snapshot Podcast

The Medtech Snapshot Podcast is a quick, one-question, one-answer digest featuring industry executives. Hear leaders offer their insights on MedTech topics, including start-up management, funding, product development, M&A, finance, clinicals, manufacturing, and much more. This podcast is hosted by Travis Smith, SQR-1's own Managing Director.
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Giving Back

Square-1 Engineering is proud to support local non-profits.

DeviceAlliance

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​SQR1 is a platinum corporate sponsor of DeviceAlliance, Southern California's only non-profit professional association serving the medical device industry.  

T'ena Health

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T’ena Health is a nonprofit organization that provides health disparities through resources, knowledge, and compassion to marginalized communities. We are honored to serve our community. 

Second Harvest Food Bank

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We actively support the Second Harvest Food Bank, the largest nonprofit hunger relief organization leading the fight to end hunger in the Orange County, CA community.

White Papers &​ Articles

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The History of Southern California Medical Device
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Site ​Navigation

Home
Services
Case Studies
Medtech Snapshot Podcast
White Papers/ Articles
​Contact Us
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Contact Us

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Web Content Copyright  ©   2025
  • 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
  • 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
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us