Medical Device Product
Development & Manufacturing
Virtec Medical & Virtec Enterprises Are Now DEM Medical!
Bring Your Medical Device Ideas to Life
DEM Medical develops medical devices from concept to production, meeting your specifications and strict industry standards. Our services cover everything from rapid medical device prototyping to full-scale manufacturing, providing comprehensive solutions at every stage of your project.
-
FDA registered for Class I and II medical devices
-
ISO 9001 and 13485 certified Quality Management Systems (QMS)
-
FDA 510(k) support
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.
DEM Medical’s Advantage in Medical Device Manufacturing
Product Development
As an FDA-registered manufacturer, we ensure every product meets regulatory requirements throughout development and production.
Scalable Manufacturing
Our processes are tailored to your specific production needs, from prototyping to medium-volume runs.
High Quality Standards
Our robust quality systems deliver consistent results, ensuring every product meets rigorous performance and reliability expectations.
A Proven Process for Medical Device Development
At DEM Medical, we follow a rigorous development process that benefits customers by streamlining production, reducing risks, and ensuring that products meet both regulatory and market demands.Step 1: Concept Creation & Benchmarking
We create a clean sheet design or optimize your initial concepts. Every product we develop is designed and manufactured to fulfill our customers’ performance objectives and to meet stringent FDA regulatory requirements.
Step 2: Prototyping
Rapid prototyping and initial confidence testing are completed. We then perform any necessary design iterations to ensure the product functions as intended before it is subjected to full validation testing.
Step 3: Product Validation
DEM Medical provides you with production-intent samples in quantities needed to complete the validation testing. We can also work directly with outside testing facilities to coordinate the validation work.
Step 4: Conversion to High-Volume Production
We build and debug high-volume tooling, develop assembly processes, and create robust quality control plans. Once regular production is underway, we provide high-quality products by constantly monitoring important product features through our QMS systems.
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
-
Gastric calibration tubes
-
Surgical tables
-
Suction devices
-
Laparoscopic surgical devices
-
Catheters
-
Ventilatory devices
-
Laser therapy
