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Absolute EMS Completes ISO 13485:2016 Recertification, Strengthening Commitment to Medical Device Quality Systems
March 25, 2024 | Absolute EMS, Inc.Estimated reading time: 1 minute
Absolute EMS, Inc., an award-winning EMS provider of turnkey contract manufacturing services, proudly announces the successful completion of its ISO 13485:2016 audit, reaffirming its commitment to excellence in medical device manufacturing.
The ISO 13485 standard, specifically tailored to medical device quality systems, supplements the ISO 9001 standard and ensures adherence to stringent quality and regulatory requirements. Absolute EMS is dedicated to upholding the highest standards of quality, traceability and reliability in medical device manufacturing.
In addition to its ISO 13485 certification, Absolute EMS is ISO 9001:2015 and AS9100D certified, further demonstrating its commitment to quality management and continuous improvement. The company proactively manages, controls, and audits its processes, both internally and through external certification bodies, to ensure compliance with industry regulations and customer expectations.
Absolute EMS has been a trusted partner for medical product development and production for more than 27 years, offering expertise in the entire lifecycle of medical devices, from New Product Introduction (NPI) to end-of-life support. The company's state-of-the-art manufacturing facility, equipped with touchless manufacturing technology and automated inspection capabilities such as 3D Solder Paste Inspection (SPI) and X-ray technology, ensures precision and reliability in every product.
Customized quality reporting, robust device history record keeping, and traceability to the component level provide transparency and accountability throughout the manufacturing process. Absolute EMS's Counterfeit Part Prevention Program further enhances component integrity, mitigating potential risks and ensuring product safety.
Specializing in instrumentation, surgical instruments, endoscopy products, and surgical robotic arms, Absolute EMS offers a comprehensive range of capabilities tailored to meet diverse industry needs. From supporting hybrid leaded/unleaded component mixes to adhering to IPC-A-610 standards, Absolute EMS consistently exceeds industry expectations, delivering superior quality and reliability to its customers.
“We are proud to have successfully passed another ISO 13485:2016 recertification, which further validates our commitment to providing high-quality, reliable medical device manufacturing solutions,” said Doug Dow, COO at Absolute EMS. “We are dedicated to continuous improvement and customer satisfaction, ensuring that our partners receive the highest level of service and support.”
Absolute EMS is a premier provider of end-to-end electronic manufacturing services, facilitating speed-to-market for innovative technology. Based in Silicon Valley, the company offers world-class Printed Circuit Board Assembly (PCBA) services.
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