ISO 13485:2016
ISO 13485 Electronics Manufacturing
For medical device OEMs, selecting a manufacturing partner with ISO 13485 electronics manufacturing certification is not a preference – it is a program requirement. ISO 13485:2016 is the internationally recognized quality management standard specific to medical device design and production, and it sets a rigorous bar for documentation, traceability, process control, and continuous improvement. VR Industries has held ISO 13485 certification since 2011, and our quality management system is built to meet the demands of medical device customers at every stage of production.
What ISO 13485:2016 Requires of a Manufacturing Partner
ISO 13485:2016 goes significantly beyond the requirements of ISO 9001. Where ISO 9001 establishes a general quality management framework, ISO 13485 adds requirements specific to the medical device industry – including enhanced risk management, stricter documentation control, and more rigorous controls over production and service provision.
For OEMs evaluating an ISO 13485 contract manufacturer, certification signals that a facility operates under a quality management system designed specifically for the complexity and regulatory stakes of medical device production. At VR Industries, that means:
- Revision-controlled build documentation maintained for every product and process
- Full material traceability through our customized ERP system, from incoming components through final shipment
- Robust corrective and preventive action (CAPA) procedures
- Routine internal audits and third-party certification reviews through NQA USA
- Documented process controls governing every stage of assembly, inspection, and test
Have Questions About Our ISO 13485 Certified Processes?
Our team is happy to walk you through our quality management system, traceability protocols, and audit history. Reach out and we will connect you with the right person.
Built for the Complexity of Medical Device Contract Manufacturing
Our ISO 13485 certified quality management system supports medical device contract manufacturing for moderate to complex printed circuit board assemblies, sub-assemblies, and full system integrations. We manufacture products ranging from handheld units to floor-mounted systems for some of the leading medical device OEMs in the country.
Our quality infrastructure includes in-process automated optical inspection (AOI), in-circuit testing, functional testing, X-ray inspection, and burn-in services – all operating within the structured framework our ISO 13485 certification requires. As an FDA registered medical device manufacturer, our facility and processes are subject to additional regulatory oversight that further validates our commitment to compliance.
ISO 13485 certified manufacturing also works in concert with our J-STD-001 Space Addendum Class 3 certified workforce and our ISO 9001:2015 quality management system, giving medical device customers a manufacturing partner whose quality credentials span the full scope of their program requirements.
Ready to Work With an ISO 13485 Certified Electronics Manufacturer?
Tell us about your medical device program and we will outline how our quality management system supports your production and compliance requirements.