Fulfill Your Manufacturing Needs Today and Start Planning for What’s Next

With integrated medical device contract manufacturing solutions, we can support your small and large scale builds while also engaging engineering to develop your future generation system.

Experience partnership, process efficiency and high-quality production that stands out among medical device contract manufacturers

Highest Quality Standards
Highest Quality Standards

As an FDA registered and ISO13485 certified contract manufacturer, our testing and processes ensure your medical device is produced to the highest quality standards.

Engineering Access
Engineering Access

Our engineers are under the same roof and accessible at all times. We can engage team members with expertise in your technology to troubleshoot or even start planning for next generation.

Production Scalability & Cost Down Strategies
Production Scalability & Cost Down Strategies

Known for our flexibility in medical device contract manufacturing, we support first-in-human and small quantity builds and can scale for your demand.

Global Distribution
Global Distribution

Our skilled technicians are trained specifically in medical device manufacturing, following our proven processes to get product to you reliably, domestically and across the globe.

Component Obsolescence
Component Obsolescence

Supply chain management is on-going and electrical components commonly go obsolete. We’ll secure last time buys to maintain production continuity while also plan for future replacement efforts.

Device Service & Restoration
Device Service & Restoration

Our team proactively works with you during production to develop servicing and refurbishment plans to minimize disruptive system downtime.

Manufacturing support of your short and long term needs, scaling with you

Explore our comprehensive manufacturing solutions- external transfers into production, transitions from development to production, refurbishments, upgrades and helping with your next generation system.


Frequently Asked Questions

What Is Medical Device Contract Manufacturing?

Medical device contract manufacturing is a service where a company specializes in producing medical devices for other businesses.

This process can include the creation of prototypes, large-scale production, and assembly of a wide range of medical devices.

By outsourcing production to Vantage MedTech, you can focus on core activities like research and development, while we ensure the devices meet all industry standards and regulations.

What Regulations Govern Medical Device Contract Manufacturing?

Medical device contract manufacturing is governed by stringent regulations to ensure safety and effectiveness. In the United States, the Food and Drug Administration (FDA) sets these regulations under the Federal Food, Drug, and Cosmetic Act.

Global manufacturers must adhere to the International Organization for Standardization (ISO), specifically ISO 13485, which sets international standards for quality management systems in the design and manufacture of medical devices.

Can Contract Manufacturers Assist With Prototype Development For Medical Devices?

Contract manufacturers can assist with prototype development for medical devices. We offer comprehensive services that include design assistance, material selection, and the creation of functional prototypes.

This process allows for testing and refinement of medical devices before mass production. Our expertise in engineering and manufacturing ensures prototypes are developed efficiently and adhere to necessary regulatory standards.

What Is The Typical Timeline For a Medical Device Manufacturing Project?

The typical timeline for a medical device manufacturing project varies based on the complexity of the device and the project's scope.

However, most devices do generally go through the same series of steps.

  1. Design
  2. Prototyping
  3. Testing
  4. Regulatory approvals
  5. Mass production

Vantage MedTech works closely with clients to establish a detailed project timeline, considering all critical milestones. Our aim is to optimize the manufacturing process for efficiency without compromising on quality.

What Are The Most Common Materials Used in Medical Device Manufacturing?

In medical device manufacturing, materials are selected based on the device's intended use, durability requirements, and compliance with medical standards.

Common materials include:

  • Medical-grade plastics, like polyethylene and polypropylene, for their flexibility and lightweight nature
  • Metals such as stainless steel and titanium, chosen for strength and corrosion resistance, ideal for surgical instruments and implants
  • Silicone, its flexibility and biocompatibility make it suitable for various medical applications