The Medtech Problem Solvers

6 Morgan, Ste 125, Irvine, CA 92618

End-to-End Consulting for the Entire Medical Device Lifecycle

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!

How We Help

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

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.
You can keep wondering if this is what your company needs, or you can find out with a click of a button.
Give Us a Call: +1 (844)-300-SQR1
Or you can request a callback here**

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

Our Services

MedTech Consulting

​Experts in Class II & III R&D, RAQA & Mfg Engineering
See Consulting Options

CAD Services

​Mechanical & Electrical Design, Drafting & cGMP Documentation
Learn About CAD Capabilities

Technical Training

​Whether it's Regulations, Compliance, or CAD: we help you grow.
View Training Options
Validation
Manufacturing Engineering
One-Day Gap Assessment
Technical Training
Medical Device Training
Problems We Solve

A highly motivated team of experts at your disposal.

​Square-1 Engineering is powered by two teams working hand-in-hand: our Home Base, who keep projects moving and clients supported, and our Field Team — the engineers and compliance specialists driving results on the ground. Together, we bring the expertise and collaboration to help your MedTech projects succeed.
Case Studies
MedTech Expertise
Project Expertise

Project Execution

​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.
Still on the fence?
Read Our FAQs
We understand you may have questions, and we are happy to answer any that aren't on that page. Just fill out our contact form and we will get those questions answered ASAP.

​Giving Back

We believe success means more when it’s shared and Square-1 Engineering is proud to support local non-profits.
Each quarter, Square-1 Engineering partners with local non-profits to give back to our community supporting causes that make a difference close to home. Click on a logo to learn more about their organization.

DeviceAlliance

​SQR1 is a platinum corporate sponsor of DeviceAlliance, Southern California's only non-profit professional association serving the medical device industry.  
Their mission: "DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation and career development for all device professionals in Southern California.
DeviceAlliance is the only multi-disciplinary, non-profit, professionals association serving the medical device industry in Southern California.  That’s why we’re the ideal place to help support medical device professionals as they formulate start-ups, expand market share for a Fortune 500 corporation or grow their individual careers."

Visit their Website​

TENA

TENA is a nonprofit organization that provides health disparities through resources, knowledge, and compassion to marginalized communities. We are honored to serve our community.
​
From their website:
"TENA recognizes that access to quality healthcare, resources, and health education can be difficult to obtain in many communities, and works hard to bridge this gap. Composed primarily of Los Angeles County natives, the team draws upon the social determinants of health to provide services that support the health and wellness of their neighborhoods and beyond. TENA believes in empowering others to have the tools, knowledge, and resources they need to live a healthy and enriched life."
See their cause​

​Second Harvest Food Bank

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.
​
From SecondHarvest: 
"As a large regional food bank, we provide food for all who need it with a concentrated focus on our most vulnerable populations—children, working families, college students and seniors.
We purchase nutritious food and shelf-stable items—and grow a portion of our own produce—for distribution through our Partner Network, which provides food at more than 300 locations throughout Orange County."
Get Involved

Our results speak for themselves—and so do our clients. Here’s what they’re saying about working with the SQR1 team.

  • Client Testimonials
  • Google Reviews
​Vice President of QA, RA, & Operations
Medical Device Company
"​Square-1 Engineering has been influential in helping me with well over two dozen engineering projects. Square-1 takes ownership, responsibility, and pride in providing the best technical consulting services. They take the role of a trusted advisor. They listen, understand, and deliver a successful solution."
​Senior Project Engineering Manager
Medical Device Company
​"It's refreshing working with a service provider that is honest and trustworthy, as well as technically capable of handling a variety of product design, manufacturing, and test work. Square-1's follow-through makes them a service provider worth keeping around for the long term."
CEO
​Southern California Cardiac Management Start-Up
"Working with [the SQR1 team] has been amazing. You all really nailed these projects out of the park, making it easier for us to head into trials."
VP R&D
San Diego Medical Device Company
"We needed to quickly identify high-quality engineering support in the fall of 2021. The SQR1 team responded with incredible speed, tenacity, and competence. In an environment where competition for engineers was at an all-time high, the SQR1 team aggressively succeeded in finding solutions. We brought on three people from their team, which helped us deliver on mission critical objectives. In the future, when engineering support is required, SQR1 will be a first call."
Verified Google Reviews

The MedTech Snapshot Podcast

The Medtech Snapshot Podcast is a quick, one-question, one-answer digest featuring medical device 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. Hosted by Travis Smith, SQR1's founder and managing director, listening to one episode you'll find the content and brevity is honey to your ears!

Recent Articles

Overcoming Harsh Realities of Entrepreneurship
Read and Watch Here
CEO of Finally Quiet! discusses the realities of starting in MedTech and the ways to overcome these challenges.
PFAS in the Medical Device Industry: ​The history, use, regulation and the path forward.
Read Full White Paper
This white paper explores the history of Per- and polyfluoroalkyl substances (PFAS), how they are used in medical technology, why regulatory bodies have pushed for their removal, and strategies for Medtech companies to successfully manage this transition. ​
The Biggest Miss in Medical Device Skills Training
Read Article
 To promote someone into a job which they’ve not done prior and then not offer training to do said job, is one of the biggest mistakes a company can make. ​

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Quick Answers
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