ISO 13485 certification in all global manufacturing, design locations

Mexicali, Mexico – Creation Technologies’ electronics manufacturing facility in Mexicali, Mexico, is the company’s latest to receive the ISO 13485:2003 certification. All ten manufacturing facilities and 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.”

Other news from Creation is 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.

Source: Creation Technologies