Full Lifecycle Solutions

Expertise across the device lifecycle.

Our dedicated expertise from development through commercialization and technology-specific processes get your device to market faster, without sacrificing quality.

We can handle the entire process, so you can focus on the big picture.

Why bother with a partner that can’t deliver a truly complete solution? Our comprehensive and synergistic approach creates a more seamless experience from project kickoff through product delivery. This means we do more than design and manufacture—we’re addressing the supply chain, supporting and clearing your path to regulatory approval, and applying quality management disciplines to provide the best product in the least amount of time. Across it all, we keep you up to date on your project through our Vital Link project management platform.

Learn about our Strategic Approach

Design & Development

Our skilled teams of engineers and scientists design for usability, function and performance. All products are built for efficient manufacturing.

Quality

Our Quality Management System (QMS) meets or exceeds all medical device requirements.

Regulatory Support

Our focused clinical experience supports successful navigation of regulatory requirements and a strong QMS system.

New Product Introduction

Our New Product Introduction (NPI) process streamlines transfers, reduces risks and increases speed to finished product.

Manufacturing

Our state-of-the-art manufacturing facility utilizes production techniques that reduce waste, elevate quality and continuously seek efficiencies throughout the process.

Supply Chain Management

We think about supply chain from the outset, avoiding delays and ensure quality and availability of the best components and materials in the most efficient manner.

Design & Development

Engineering that’s usable and manufacturable.

Our skilled teams design for usability, functionality and performance. From software to disposables to electromechanical systems, all products are engineered for efficient manufacturing.

  • Over 160 major 510(k) and PMA design projects completed
  • Over 2M hours of medical device engineering

Quality

Our QMS system meets all medical device requirements.

The Minnetronix Quality Management System spans design, development, manufacturing, commercialization and service of medical devices. Our continuous improvement of all aspects of the process leads to the delivery of superior medical devices.

  • Deep compliance expertise, including REACH, RoHS, conflict origin materials and International Harmonized Standards

Regulatory Support

Regulatory strategies that mitigate risk and assure compliance.

Our deep regulatory expertise helps our partners navigate FDA and CE submissions as well as achieve clearances and approvals, ensuring compliance.

  • Experience with FDA-related communications, submissions and meetings
  • Eight consecutive clean FDA audits
  • Knowledgeable about IDE, PMA and 510(k) guidance and processes
  • Audits and inspections with FDA and other notified bodies

New Product Introduction

Accelerate product development while minimizing risk.

Our structured New Product Introduction (NPI) process serves as a formal bridge from development to production, keeping your product moving fast while retaining the highest quality possible.

  • Includes Operations involvement throughout
  • Production staff provide DFM feedback
  • Ability to spot issues quickly and early
  • Minimizes delays to saleable product
  • Improves design, quality and reliability
  • Delivers manufacturable, reliable, cost-effective and available quality product

Manufacturing

Rely on our proven legacy of medical manufacturing.

Working hand-in-hand with our engineering experts, our manufacturing team proactively looks for efficiencies across the build process. From alpha prototypes to full-scale production, we accommodate the need and get it done right.

  • Configurable 150,000 ft2 / 13,935 m2 facility
  • New Product Introduction streamlines transfers and reduces risks for faster delivery
  • Controlled environment for low-particulate manufacturing
  • Experienced service team manages repairs and upgrades
  • Supply chain and engineering for support over the entire product lifecycle
  • Dedicated manufacturing teams across our four technology segments

Supply Chain Management

Unanticipated supply chain challenges shouldn’t disrupt your product.

Our comprehensive supply chain management program was built to anticipate obstacles before they arise. We’ve built a deep network of trusted suppliers and distributors, ensuring we receive the quality materials and components your project requires precisely when they’re needed.

  • Stay informed about supply and delivery status via our Vital Link project management platform
  • Mature supply chain, vetted and optimized to support our technology segments
Looking for a partner to bring your next technology to market? Let’s talk!

Call 651-917-4060 or email info@minnetronixmedical.com