Precision & Compliance in Medical Device Manufacturing
Reliable. Compliant. Scalable. Your Medical Device Manufacturing Partner.
Medical Device Contract Manufacturing Services at VR Industries
At VR Industries, we understand that medical device contract manufacturing services demand the highest levels of precision, quality, and regulatory compliance. For over four decades, we’ve partnered with innovative medical device companies to bring their health-improving technologies to market as a full service medical device contract manufacturing provider.
Why VR Industries for Medical Device Manufacturing?
Working with cutting-edge medical innovators is important to us as many of the medical devices we manufacture are used in health monitoring and patient care situations. As a medical device contract manufacturer, we provide medical device manufacturing services for moderate to complex printed circuit board assemblies, sub-assemblies and full systems to some of the top OEMs around the world. Our ISO 13485 and ISO 9001 certifications underscore our commitment to continuous improvement to support our current and prospective medical customers. This, coupled with our Class III J-STD-001 compliant workforce, gives us the capability to manufacture a broad spectrum of products, ranging in size from handheld units to floor-mounted systems. We are an FDA registered medical device manufacturer and our team has years of expertise building a variety of products.
One of our dedicated Program Managers serves as your primary point of contact throughout the manufacturing relationship, ensuring clear communication and alignment with your production objectives. This personalized attention allows us to provide proactive solutions and adapt to changing requirements, making us a trusted healthcare manufacturing partner for your complex medical device production needs.
Key elements of our medical device manufacturing expertise:
Specialized medical device supply chain management through our ERP system designed for material traceability, serialization and inventory control
Robust process and quality-control procedures to provide high reliability assemblies each and every time
Lean shop floor that is process-driven with detailed, step-by-step, revision-controlled build instructions
Quality system that incorporates x-ray, automated optical inspection, in-circuit test, functional test and burn-in
FDA registered medical device manufacturing facility with 40+ years of contract manufacturing experience
Our Capabilities in Medical Device Manufacturing
Printed Circuit Board Assembly (PCBA)
At the core of medical device electronics manufacturing, our PCBA services deliver precision-manufactured circuit boards that meet the stringent requirements of medical applications. We employ advanced Surface Mount Technology (SMT) alongside traditional Thru-Hole assembly techniques to accommodate the diverse needs of medical device manufacturers.
Every board undergoes rigorous quality verification through our Automated Optical Inspection (AOI) systems, with first article and initial production boards receiving high-resolution X-ray verification, ensuring critical components like BGAs are properly soldered and free from defects. Our manufacturing processes comply with IPC Class 3 standards for high-reliability electronics, essential for devices where failure is not an option.
Our comprehensive testing protocols can be customized based on your specific requirements, potentially incorporating in-circuit testing and functional validation to ensure each board performs exactly as designed. This multi-layered approach to quality control is particularly crucial when providing OEM contract manufacturing medical devices, as precision and reliability directly impact patient care.
Electromechanical & Box Build Assembly
Our electromechanical assembly capabilities extend well beyond basic PCB manufacturing to encompass complete medical device integration. We specialize in the assembly of complex medical systems, including the integration of electronic components, mechanical enclosures, displays, user interfaces, and interconnect wiring—all executed with precision in our controlled manufacturing environment.
Based on your specific requirements, assemblies can undergo customized functional and burn-in testing to validate performance under your defined operating conditions, helping ensure reliability in clinical settings. Our expertise in medical-grade full device and subassembly manufacturing addresses the unique challenges of medical equipment, from thermal management to EMI shielding and fluid resistance.
We configure custom manufacturing cells specifically designed around your product requirements, allowing for efficient production while maintaining the highest quality standards. This specialized approach enables us to handle the intricate assembly needs of diverse medical devices, from diagnostic equipment to patient monitoring systems.
Quality & Compliance
Medical device manufacturing demands exceptional quality systems, and we’ve built ours specifically to address the rigorous requirements of this highly regulated industry. Our ISO 13485 and ISO 9001 certified quality management systems form the foundation of our medical device manufacturing processes, ensuring consistent adherence to international standards for medical device production.
We implement FDA-compliant processes for comprehensive risk management and validation throughout the manufacturing lifecycle. Every step in our production process is documented with meticulous detail, creating the audit trail necessary for regulatory submissions and compliance verification. Our quality team maintains detailed documentation and record-keeping systems that support your regulatory approval processes.
As an experienced medical device manufacturing partner, we provide the comprehensive manufacturing documentation needed to support your FDA clearance process. Our detailed Device Master Records (DMRs), material traceability reports, process validation records, and testing documentation can be formatted to align with your regulatory submission requirements, streamlining your path to market authorization.
Process controls and validation procedures are embedded throughout our operations, from incoming material inspection to supporting customer defined final device testing. We conduct regular internal and external audits to verify compliance with both regulatory requirements and our own exacting standards, ensuring that every medical device leaving our facility meets the highest quality benchmarks.
Supply Chain & Risk Management
The integrity of the medical device supply chain directly impacts product quality and regulatory compliance. Our specialized supply chain management systems are designed to mitigate the unique risks associated with medical device production. We’ve developed a network of proven, verified suppliers for sourcing critical medical-grade components, ensuring consistent quality and availability even during industry-wide shortages.
Our ERP system has been specifically configured to address the complex materials management and component control requirements of medical OEMs. It provides complete traceability from raw components to finished devices, a critical capability for meeting FDA requirements and managing potential field issues.
We employ sophisticated counterfeit component detection methodologies and lifecycle management protocols to protect the integrity of your products. Our comprehensive approach includes visual examination, electrical testing, and high-resolution X-ray inspection to verify component authenticity. Additionally, our inventory and logistics solutions are tailored to accommodate the unique demands of medical device production schedules, ensuring continuity of supply while minimizing excess inventory costs.
Medical Applications We Support
Our medical device manufacturing services excel in producing equipment for various healthcare applications:
Patient Monitoring & Wearable Devices
We manufacture reliable electronics for continuous health tracking systems, ensuring accuracy and dependability for critical patient data collection.
Surgical &
Imaging Equipment
Our high-precision PCBAs and assemblies power sophisticated surgical instruments and imaging systems where failure is not an option.
Diagnostic
Laboratory Devices
We ensure accuracy and reliability in lab and point-of-care testing equipment through precise manufacturing and rigorous quality controls.
Therapeutic & Rehabilitation Devices
Our advanced electromechanical integration capabilities support innovative therapeutic and rehabilitation technologies.
The VR Industries Advantage for Medical Devices
At VR Industries you will witness a lean shop floor that is process-driven with detailed, step-by-step, revision-controlled build instructions. Our quality system incorporates:
X-ray inspection for critical component verification
Automated optical inspection for consistent quality
In-circuit testing to validate functionality
Functional testing to ensure performance
Burn-in procedures to identify potential failures
Complete traceability from component to finished device
Materials management and component control can be a significant concern with medical OEMs. VR Industries’ ERP system has been specifically designed to accommodate material traceability, serialization and inventory control.
Robust process and quality-control procedures are key elements to providing high reliability assemblies each and every time. We take care in servicing our medical OEMs and the products we build for them. Audits typically consist of critical material verification, manufacturing process review, and general ISO quality standards review. Quality counts when health and wellness is your goal.
Partner with VR Industries
Whether you need a prototype or full-scale production, VR Industries stands among leading medical device contract manufacturers ensuring precision, compliance, and reliability at every step of the manufacturing process. Our dedicated Program Managers provide personalized attention to your project, ensuring clear communication and alignment with your objectives.
We take care in servicing our medical OEMs and the products we build for them. Our medical device supply chain management and quality systems are designed specifically for the demanding requirements of the healthcare industry. Partner with us as your medical device manufacturing partner to bring your innovative medical devices to market with confidence in quality, compliance, and on-time delivery.
Get in Touch with our team to discuss your medical device contract manufacturing services needs.