At its location in Cranston, Rhode Island, Federal Electronics has successfully completed its 2025 ISO 13485:2016 surveillance audit. The audit’s accomplishment signifies ten years in a row of accreditation to the globally accepted medical device manufacturing quality standard.
In 2015, Federal Electronics became the first company to receive ISO 13485 accreditation.
Since then, the company has successfully completed third-party audits confirming adherence to the standard’s requirements, which include risk management, documentation control, traceability, and consistent production methods.
This accomplishment demonstrates that the business’s quality management system is still meeting the requirements of regulatory agencies and consumers of medical devices.
Federal Electronics was established in 1961 and supplies OEMs in the medical, military, aerospace, instrumentation, and industrial automation industries with printed circuit board assembly, electromechanical integration, and system-level builds.
Supporting complex, low-to-mid-volume initiatives that call for dependable process control, end-to-end supply chain management, and deep engineering collaboration is the company’s specialty.
Federal has two manufacturing facilities: one in the low-cost region in Hermosillo, Mexico, and company headquarters in Cranston, Rhode Island. Customers can take advantage of flexible sourcing models because both locations adhere to coordinated quality and operational processes.
Leadership Comments
“Reaching the 10-year mark with ISO 13485 reflects the strength and stability of our quality system,” said Ed Evangelista, President at Federal Electronics. “We’ve built the structure and discipline necessary to support complex medical assemblies, and we’re able to apply that same control across all the industries we serve.”
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