As a trusted medical device manufacturing partner, we deliver precision-engineered, compliant solutions for Class I and II medical devices supporting medical OEMs from design through delivery.
Our services combine engineering, validation, and full production with stringent quality management systems to ensure safety, reliability, and regulatory compliance at every stage. From medical device prototypes to low to mid-volume production, and high-level assemblies, our teams operate with the precision and accountability required in today’s medical and life sciences industries.
Medical device manufacturing & compliance
We understand the complexity of regulated medical manufacturing, where every component, process, and verification stage matters. Virtex offers complete manufacturing support built on ISO 13485 certification and FDA 21 CFR Part 820 compliance, ensuring your products meet the highest global standards.
Services include:
- Design and Development Support
- Validation and Verification Testing
- Class I and II Medical Device Manufacturing
- PCBA, Cable, and System-Level Assembly
- High-Level Assembly and Box Builds
- Final Packaging, Labeling, and Logistics
- Regulatory and Documentation Management
- Product Traceability and Serialization
Supporting manufacturing with the quality and control trusted by leading medical device manufacturers.
Market experience
We serve medical and life science customers across a range of applications that demand accuracy, consistency, and performance.
Experience includes:
- In Vitro Diagnostics
- Imaging Devices and Equipment
- Drug Delivery Systems
- Patient Monitoring and Digital Health Devices
- Surgical and Therapeutic Equipment
- Laboratory and Analytical Instruments
Certified to the highest standards
Our commitment to quality and compliance is reflected in our certifications and ongoing investment in regulated manufacturing systems.
Certifications & standards:
- ISO 13485:2016 – Medical device quality management system
- FDA 21 CFR Part 820 – Quality System Regulation (QSR)
- ISO 9001:2015 and AS9100D – Certified for consistent, process-driven excellence
- J-STD-001 / IPC-A-610 Class II & III – Standards for high-reliability electronic assemblies
- ANSI/ESD S20.20 – ESD protection and process control
- RoHS and WEEE Compliant – Environmentally responsible manufacturing practices
