Creation Technologies Achieves ISO 13485 Certification for All Facilities


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Creation Technologies, a leading global provider of electronics manufacturing and design services, has achieved ISO 13485 certification in all of its business units across the United States, Canada, Mexico and China.

The EMS provider, known in the EMS industry for its entrepreneurial and customer-focused approach, announced that its electronics manufacturing facility in Mexicali, Mexico, is the company's latest to receive the ISO 13485:2003 certification, an internationally recognized quality standard for medical devices and diagnostics. All ten of Creation’s manufacturing facilities and its two design centers are now ISO 13485-certified.

"Creation offers our customers the unique advantage of an integrated design-through-after-market solution with the same core team focused on getting products to market as quickly as possible," said Sergio Quiroz, General Manager of Creation Technologies – Mexicali. "As regulatory requirements and global cost pressures for medical OEMs continue to grow, our customers count on us for expert execution of highly complex, diverse and demanding projects. The ISO 13485 certification demonstrates our ability to deliver."

Creation made other recent medical industry news when its CEO, Bhawnesh Mathur, spoke on manufacturing and innovation at New York's MEDTECH 2015. Mathur, who also chairs IPC's Government Relations Committee and was integral to shaping IPC policy around Conflict Minerals, believes innovation and collaboration are inherently linked, particularly in highly-regulated industries.

"Helping our customers commercialize and sustain innovative medical devices is of critical importance to Creation Technologies, and, we believe, to the future of economic growth in North America," said Mathur. "We have made a long-term investment in the infrastructure and systems that we know will help our customers get their medical devices to market at top speed with the utmost attention to quality and reliability."

In addition to the company's ISO 13485 certifications, some of this infrastructure includes FDA-registered business units and Creation Technologies' proprietary 'Vision' Customer Portal and Manufacturing Execution System (MES). These systems have been validated as compliant with Title 21 CFR Part 11 of the Code of Federal Regulations, and provide Creation Technologies' customers with the proof of quality assurance and traceability that are critical to successful medical device manufacturing.

Creation Technologies is exhibiting this week at Booth #571 at MD&M West in Anaheim, California.

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