FDA Registered
FDA Registered Medical Device Manufacturer
Medical device OEMs operate in one of the most heavily regulated manufacturing environments in the world. Selecting a manufacturing partner that holds proper FDA registration is not optional – it is a foundational requirement for maintaining your own compliance posture. VR Industries is an FDA registered medical device manufacturer, meaning our facility has met the registration requirements set by the U.S. Food and Drug Administration for establishments involved in the production of medical devices intended for use in the United States.
What FDA Facility Registration Means
The FDA requires owners and operators of establishments involved in medical device production and distribution to register annually with the agency. This process, known as establishment registration, subjects our facility to FDA oversight and ensures that our manufacturing operations remain visible to and accountable under federal regulatory authority.
For medical device OEMs, working with an FDA registered contract manufacturer means your supply chain includes a facility that operates under that same regulatory framework. It simplifies your own audit and compliance obligations, and it demonstrates to your customers and regulators that your manufacturing partners meet federally recognized standards for medical device production.
At VR Industries, our FDA registered facility status works alongside our broader quality infrastructure to support the full compliance requirements of our medical device customers:
- ISO 13485:2016 certified quality management system for medical device manufacturing
- Full material traceability through our customized ERP system, from incoming components through final shipment
- Revision-controlled, step-by-step build documentation maintained for every product
- In-process automated optical inspection, X-ray inspection, in-circuit testing, and functional testing
- Routine internal and third-party audits conducted through NQA USA
Have Questions About Our FDA Registered Manufacturing Facility?
Our team is happy to walk you through our facility registration, quality management system, and medical device manufacturing capabilities. Reach out and we will connect you with the right person.
Supporting Medical Device OEMs Across the Production Lifecycle
Our FDA registered manufacturing capabilities support medical device contract manufacturing for moderate to complex printed circuit board assemblies, sub-assemblies, and fully integrated systems. We manufacture products ranging from handheld monitoring units to floor-mounted systems for medical device OEMs, applying the same disciplined quality and documentation controls to every program regardless of scale.
Our Customer Innovation Center (CIC) and New Product Introduction (NPI) services give medical device OEMs direct access to our production and engineering experts early in the development cycle, reducing compliance risk before a product ever reaches full-scale production. When programs move into production, each customer is supported by a dedicated Program Manager who maintains oversight of scheduling, quality reporting, and documentation throughout the program lifecycle.
For medical device customers with the most demanding quality requirements, our ISO 13485:2016 certification and FDA registered facility status represent the foundation of a manufacturing partnership built around regulatory accountability and production excellence.
Ready to Work With an FDA Registered Medical Device Manufacturer?
Tell us about your program and we will outline how VR Industries can support your compliance and production requirements.