Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
Home  >  Project Execution  >  Our Approach
Our take on medical device consulting:
We tailor our consulting to fit your needs—combining hands-on technical expertise with strategic guidance to drive successful project outcomes.
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What to expect when we work together:

We take a collaborative, results-driven approach to consulting. From day one, we listen to understand your goals, challenges, and project needs. Our team integrates seamlessly with yours, providing hands-on technical expertise and strategic support to keep projects on track. With a focus on efficiency, compliance, and innovation, we adapt to your workflow, ensuring a smooth and successful outcome—whether it’s a short-term solution or a long-term engagement.
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From large-scale projects like multi-year remediation efforts to short-term support such as gap assessments or CAD conversions, we adapt to your needs—delivering expert guidance, efficiency, and lasting impact.

Challenges we solve:

Subject Matter Experts:
  • Change in key personnel
  • M&A due diligence
  • Audit Preparedness
  • ​Advisory & Validation
Project Bottlenecks
  • Milestone attainment
  • Regulatory events (remediation, submission)
  • Change in supply chain
Limited Bandwidth
  • Significant growth
  • New funding
  • M&A integration
  • Facility transfers
  • Layoffs

How we can help:

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Medical Device Consulting
Expertise 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.
All Services

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

Ready to move forward?

Let's start a conversation.
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Case Studies & White Papers

Our case studies showcase how we deliver practical solutions, improve processes, and drive successful project outcomes. Check out a few highlights below.
See all case studies
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CAD Outsourcing, SQR1 Case Study
File Size: 211 kb
File Type: pdf
Download File

Class III Remediation, SQR1 Case Study
File Size: 92 kb
File Type: pdf
Download File

Enhancing Operational Efficiencies, SQR1 White Paper
File Size: 624 kb
File Type: pdf
Download File

Product Development Design Standards, SQR1 White Paper
File Size: 371 kb
File Type: pdf
Download File

White Papers &​ Articles

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The History of Southern California Medical Device
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White Papers/ Articles
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      • Medical Device Training
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    • How We Engage
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  • About Us
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    • 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