Ark Electronics Receives ISO 13485 Certification for Medical Equipment Manufacturing

IRVINE, Calif., Oct. 3, 2023 /PRNewswire/ — Ark Electronics, a leading global contract manufacturer specializing in end-to-end electronic manufacturing solutions (EMS) and PCB Assembly, announced that it has earned the Medical Equipment Quality Management Certification from the Geneva, Switzerland-based International Organization for Standards (ISO). This internationally agreed upon and highly sought-after ISO 13485 standard is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacturing of medical devices.

Manufacturing safety and quality are non-negotiable in the medical devices industry.

Earning this certification confirms that Ark Electronics has met all the requirements for a quality management system and demonstrated its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).

“Safety and quality are non-negotiable in the medical devices industry. That’s why we developed the highest-quality manufacturing processes and utilize the most rigorous standards, with a zero-tolerance policy for defects. In doing so, we easily meet the ISO requirements for medical devices,” said Scott Wiley, President of Irvine, CA-based Ark Electronics. “This ISO certification, along with the many other ISO and independent third-party certifications we have received, gives our clients the assurances they value and deserve when it comes to the quality manufacturing and delivery of their products.”

Ark Electronics other IOS Quality Assurance certifications include:

ISO 9001 – Quality Management System Certification,
ISO 14001 – Environmental Management System Certification,
ISO 45001 – Occupational Health & Safety Certification
ISO 27001 – Info Security Management System Certification
NQA: IATF 16949 – Automotive Quality Management System Certification

Located in North America, China, and Europe, Ark Electronics is a global Electronics Manufacturing Services (EMS) provider serving leading consumer electronics, mobile communications, automotive, and industrial IoT companies. We combine technical expertise with agile manufacturing and supply chain processes, enabling our customers to create and supply original products and solutions at scale to their global OEM Customers.

To learn more, contact Ark Electronics here.

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