Medical device veterans

Making medical device development better for patients and partners.

We are a team of medical device veterans with decades of hands-on experience in product design, process development, manufacturing, project management, quality and regulatory support.

Who we are

Medical device veterans

We are medical device veterans with decades of hands-on exprience grouped together to make medical device development better and ultimately help patients. Our backgrounds span:

  • Product design and development
  • Process development and optimization
  • Manufacturing and operations support
  • Project and program management
  • Quality system and Regulatory support
Decades of industry experience
Hands-on engineering & operations
Concept to production support

How we work

We integrate with your team, whether you are an early-stage startup or an established manufacturer. Our goal is to make your development path smoother, faster, and more robust — without losing sight of patient safety and quality.

We can engage on targeted problems or support full product and process development programs.

What we can do

Product design
Concept → detailed design
  • Medical Device Product Design
  • Manufacturing & Assembly Design
  • CAD Design, FEA, Tooling, Mold & Fixture Design
Process development
Stable, scalable processes
  • Process Development and Optimization
  • Prototype Build-ups
  • Production Tranfers
Quality & Regulatory support
Quality & compliance
  • Support for Device Regulatory Pathways
  • Documentation for Submissions
  • QMS Consulting and Implementation
Project Management
Coordinated Execution
  • Project Planning and Roadmapping
  • Cross-functional Coordination
  • Risk and Issue Management
Manufacturing support
Building reliable supply
  • Scale-up and Validation Support
  • Vendor and Supplier Engagement
  • On-site Troubleshooting & Improvement
Technical consulting
Targeted expertise
  • Troubleshooting Manufacturing Processes
  • Design and Process Reviews
  • Training and Mentoring Internal Teams

In House Technical Capabilities

  • Class 7 Cleanroom
  • LSR Molding
  • Plastic Injection Molding
  • Tipping & Split Die Bonding
  • Reflow
  • Assembly
  • Packaging
  • Testing & Inspection
  • Solidworks CAD Design
  • Mold, Tooling & Fixture Design
  • Moldflow Analysis
  • FEA Analysis
  • QMS Consulting & Implementation
  • Regulatory Support & Execution

Let’s talk about your next device.

Share a brief description of your project, and we’ll discuss how our team can support your product design, process development, or manufacturing needs.

10550 County Road 81, STE 219,
Maple Grove, MN 55369
(612) 466-0488