Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
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Product Development Expertise

Supporting Medical Device Development

Our team provides technical and strategic support across every stage of product development—from concept and design to testing, validation, and commercialization. We help clients navigate challenges, optimize processes, and ensure compliance so they can move forward with confidence.
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Your partner in MedTech.

​We guide medical devices from concept to commercialization with expert design, testing, and manufacturing support.
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Design & Engineering

We focus on creating safe, effective products.
  • Feasibility Studies
  • Regulatory Classification (Class I, II (a & b), III)
  • Risk Management
  • Material Selection & Characterization
  • Systems Engineering
  • Design Assurance

Manufacturing & Compliance

Our clients' products are manufacturable, compliant, and ready for the real-world.
  • Sterilization
  • Packaging
  • Pre-Compliance Evaluation & Testing
  • Process Development
  • Validation & Verification
  • Plastic Injection Molded Components
  • Surgical Instrumentation
  • Disposables

Product Launch & Lifecycle Management

Bringing products to market and supporting supply chains.​
  • New Product Introduction (NPI)
  • Project Management
  • Supplier Acquisition

Product Experience

​We support medical device companies across a wide range of specialties, bringing deep technical expertise to each project. Our team understands the complexities of product design, compliance, and manufacturing—helping you navigate challenges at every stage.

Minimally Invasive & Delivery Systems

Precision-engineered devices for targeted treatment and therapy.
  • Neurovascular implants (stents, coils, catheters)
  • Endovascular systems
  • Drug delivery devices
  • Class I, II, III

Diagnostics & Monitoring

Advanced tools for detecting and tracking patient health.
  • Point-of-care and lab diagnostics
  • Sensing & monitoring systems
  • Vision-based technologies

Surgical & Implantable Devices

Innovative solutions for surgery and implantation.​
  • Ophthalmic implants (IOLs, ICLs)
  • Surgical instrumentation
  • Wearable health & rehabilitation devices
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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

How can we help?

Let's start a conversation.
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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.
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1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line

SolidWorks: Quick tips for enclosure surfacing

In this video learn how to use the sweep and loft functions to create complex shapes. Once the console is complete, we recommend splitting the model into multiple parts to aid in proper design for manufacturing (DFM) and ease of assembly.
See the full video

White Papers &​ Articles

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The History of Southern California Medical Device
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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