Nolan’s Notes: Finding Your Sweet Spot
Standard of Excellence: Delivering Excellence—A Daily Goal
Knocking Down the Bone Pile: Tin Whisker Mitigation in Aerospace Applications, Part 3
Ark Electronics Receives ISO 13485 Certification for Medical Equipment Manufacturing
October 19, 2023 | Ark ElectronicsEstimated reading time: 1 minute
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.
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 ISO 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
Share on:
Suggested Items
Inside Aimtron’s Cross-border EMS Strategy
07/08/2025 | Nolan Johnson, SMT007 MagazineMukesh Vasani immigrated from a very small farming village in India to the U.S. in 1995 as a civil engineer. After shifting into electronics, Mukesh built his Chicago-based company, Aimtron, into a successful enterprise by combining quality with competitive pricing. He leveraged his roots in India to expand manufacturing without compromising on quality.
Trouble in Your Tank: Can You Drill the Perfect Hole?
07/07/2025 | Michael Carano -- Column: Trouble in Your TankIn the movie “Friday Night Lights,” the head football coach (played by Billy Bob Thornton) addresses his high school football team on a hot day in August in West Texas. He asks his players one question: “Can you be perfect?” That is an interesting question, in football and the printed circuit board fabrication world, where being perfect is somewhat elusive. When it comes to mechanical drilling and via formation, can you drill the perfect hole time after time?
Driving Innovation: Direct Imaging vs. Conventional Exposure
07/01/2025 | Simon Khesin -- Column: Driving InnovationMy first camera used Kodak film. I even experimented with developing photos in the bathroom, though I usually dropped the film off at a Kodak center and received the prints two weeks later, only to discover that some images were out of focus or poorly framed. Today, every smartphone contains a high-quality camera capable of producing stunning images instantly.
TT Electronics Achieves ISO 13485 Medical Certification at Mexicali EMS Facility
06/27/2025 | TT ElectronicsThis milestone underscores TT Electronics’ commitment to delivering high-quality, compliant, and reliable manufacturing solutions to its global customers in healthcare and life sciences.
The Death of the Microsection
06/26/2025 | Bob Neves, Reliability Assessment Solutions, Inc.I got my start out of college grinding and polishing PCB microsections. My thumbs are a bit arthritic today because of the experience (microsection grinders know what I mean). Back then, via structures were rather large, and getting to the center in six steps of grinding and polishing was easy compared to what my team has been doing recently at the lab.