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 ApproachDesign & 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) is compliant to medical device regulations.
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 180 major 510(k) (including De Novo) and 75+ PMA design projects completed
- Over 2M hours of medical device engineering
Quality
Our QMS 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
- 10 FDA inspections with No Action Indicated (Minnetronix, Inc)
- 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 175,000 ft2 / 16,258 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