FDA-Registered Medical Device Manufacturing, From Prototype to Production
DEM Medical is an FDA-registered manufacturer of Class I and Class II medical devices, operating an ISO 13485:2016-certified quality system entirely within the United States. As an ISO 13485 electronics manufacturer with domestic design, injection molding, electronics, and assembly under one roof, we help innovators bring compliant devices to market faster and with less risk.
Our regulatory footprint is the starting point, not the differentiator. DEM is FDA registered for Class I and II devices (Registration #3030708724), holds ISO 9001:2015 and ISO 13485:2016 certifications, and supports FDA 510(k) submissions. As a medical device manufacturing company that medical OEMs can readily audit and qualify, we keep traceability, validation, and documentation within one accountable, U.S.-based system.
Virtec Medical & Virtec Enterprises Are Now DEM Medical!
Bring Your Medical Device Ideas to Life
DEM Medical supports medical device product development from concept to production, meeting your specifications and strict industry standards. Our services span medical device prototype manufacturing through full-scale production, providing product realization at every stage. From Class I medical device manufacturing to more demanding builds, we build to FDA regulatory requirements for quality, safety, and performance.
-
FDA-registered for Class I and Class II medical devices
-
ISO 9001 and ISO 13485 certified Quality Management Systems (QMS)
-
FDA 510(k) documentation support, with traceable design history files
-
In-house molding, electronics, and medical device assembly services within one quality system
Shorten the Time Between Concept & Production
Our streamlined process moves your product efficiently from concept to prototype and into production. And our scalable solutions provide the support you need, regardless of project size.
- We start by understanding your product, goals, and challenges to ensure we’re the right partner.
- Then, we collaborate to create a detailed project requirements plan, defining scope and performance standards.
- Next, we deliver a clear proposal with milestones for every deliverable, ensuring predictable timeliness for your medical device development.
DEM Medical’s Advantage in Medical Device Manufacturing
Product Development
As an FDA-registered manufacturer, we ensure every product meets regulatory requirements across medical device engineering, prototyping, and production.
Scalable Manufacturing
Our processes are tailored to your specific production needs, from prototyping to medium-volume runs.
High Quality Standards
Our robust QMS delivers consistent results, ensuring each device meets the reliability and performance expectations of modern medical device product development.
A Proven Process for Medical Device Development
For medical OEMs seeking a reliable, U.S.-based partner from concept through commercialization, DEM Medical brings the certifications, traceability, and process discipline that regulated work demands. Talk to an expert about your device.Step 1: Concept Creation & Benchmarking
A clean-sheet design or optimization of your concepts to meet performance objectives and FDA requirements.
Step 2: Prototyping
Rapid prototyping and initial confidence testing, followed by design iterations before full validation.
Step 3: Product Validation
Production-intent samples in the quantities needed to complete validation testing, with support coordinating outside testing facilities.
Step 4: Conversion to High-Volume Production
We build and debug tooling, develop assembly processes, and maintain quality control through our QMS.
Experience in Class I and II Medical Device Applications
Our engineering solutions have contributed to many successful medical projects and products.Previous Product Applications Include:
-
Homecare dialysis and monitoring
-
Heated humidifiers
-
Surgical tables
-
Suction devices
-
Laparoscopic surgical devices
-
Catheters
-
Ventilatory devices
-
Laser therapy
Experience Across Medical Device Categories
FAQs
1. How do you support full-cycle medical device development?
From early concept refinement and prototyping to final regulatory-ready manufacturing, DEM is your partner in end-to-end medical device development. Our ISO 13485:2016-certified processes are built to help you bring compliant devices to market faster and with less risk.
2. What makes a reliable medical device manufacturing partner?
DEM's vertically integrated team handles everything in-house, from medical device engineering to tooling and production. This U.S.-based model ensures speed, compliance, and transparency that offshore vendors can’t match.
3. Can DEM help prototype and test medical device concepts before production?
Yes. We provide rapid medical device prototyping using additive manufacturing, precision machining, and in-house PCB assembly. This accelerates validation and helps you iterate designs before investing in full-scale production.
4. Can you help navigate FDA requirements for my medical device?
Yes. DEM is ISO 13485:2016 certified and FDA-registered, and we frequently assist clients with documentation and design practices that align with regulatory standards. While we don’t provide legal or submission services, our process is built to support FDA-compliant medical device product development.
5. What’s the minimum volume you can support for a new medical device?
We offer flexible order volumes and can support early-stage medical device manufacturing with low-volume production. This is ideal for startups or pilot programs looking to scale after clinical validation or initial launch.
6. As a medical device contract manufacturer, do you help with FDA 510(k) submissions?
As a medical device contract manufacturer, we support your FDA 510(k) submission with traceable design history files, risk management records, and process validation documentation, though we do not provide legal or submission filing services ourselves.
7. Do your medical device engineering services cover both electronics and mechanical design?
Yes. Our medical device engineering services cover mechanical and electrical design together, including PCB layout, materials selection, and enclosure design, so connected and electro-mechanical devices are engineered as one integrated system.
8. Can you handle medical electronics manufacturing and molded housings within the same facility?
Yes. We keep medical electronics manufacturing, injection molding, and final assembly under one ISO 13485 quality system, so connected devices are built domestically without coordinating molded parts, electronics, and assembly across separate vendors.
9. What support do you provide as we approach medical device commercialization and scale-up?
As you approach medical device commercialization, we build and debug production tooling, develop assembly processes, and maintain quality control through our QMS, converting a validated design into repeatable, higher-volume production under one roof.
10. Does your ISO 13485 certification cover design as well as manufacturing?
Our ISO 13485:2016 certified quality system covers design and manufacturing activities for Class I and Class II devices, applying risk management, design controls, validation, and traceability across the full development and production process.
11. What classes of medical devices can DEM manufacture
DEM Medical is FDA registered to manufacture Class I and Class II medical devices, supporting applications from diagnostic and monitoring equipment to surgical instruments, catheters, suction devices, and ventilatory devices.
12. Is DEM Medical's manufacturing done in the United States?
Yes. We design and manufacture entirely in the USA under an ISO 13485:2016 quality system, which simplifies FDA alignment, keeps documentation domestic, and lets OEMs audit and qualify the facility readily.