REDCOM EMS, a business unit of REDCOM Laboratories, Inc., announced today that the company has secured ISO 13485:2016 certification, indicating its Quality Management System meets all the requirements for medical device manufacturing. The certification complements the company’s existing ISO 9001:2015 and AS9100D certifications.
“As the need for medical equipment is more important than ever, REDCOM EMS is well positioned with the recent addition of the ISO13485:2016 certification for our Quality Management System,” said Steve Husband, Vice President of Manufacturing, REDCOM and General Manager, REDCOM EMS. “With this additional certification, REDCOM EMS is pleased to offer our electronic manufacturing services to the medical device industry. This certification, along with the AS9100D:2016 and the ISO9001:2015, is a true testament to our commitment of providing a quality product to a very diverse customer base.”
Quality Engineer and Millennial in Manufacturing award winner Lauren Iuranich led the team in obtaining this certification. “This certification, in conjunction with the AS9100D certification we received last year, highlights our commitment to quality and delivering safe, mission-critical products to our customers,” Iuranich remarked. As a Quality Engineer, she’s continuously driving REDCOM EMS into the future by improving processes and systems throughout the manufacturing environment and attaining the necessary certifications.
“Our ability to obtain two certifications in less than a year demonstrates the robustness of our Quality Management System. Managing two unique sets of requirements can be challenging for small companies, but REDCOM EMS prioritizes quality and has a dedicated group of highly motivated employees to maintain requirements and produce high-quality products,” stated Iuranich.
REDCOM EMS’s ISO 13485:2016 certificate (SX 60149223) became effective on May 8, 2020, and was issued by TUV Rheinland, a certification body and global leader in independent quality inspection services. Maintaining the certification will require rigorous and comprehensive audits by the internal team and annual validation by a third-party certifying body to ensure compliance with the standard.
About REDCOM EMS
REDCOM EMS (Electronics Manufacturing Services), a business unit of REDCOM Laboratories, Inc., is a U.S.-based contract manufacturer with more than 40 years of experience manufacturing Printed Circuit Board Assemblies (PCBAs) and system-level assemblies for a diverse set of industries including Defense, Aerospace, Telecom, Industrial, Consumer Electronics, Medical, and Transportation. With a NIST-compliant secure facility, customers can trust REDCOM EMS to protect their intellectual property and manufacturing identity. REDCOM EMS’ Quality Management System is certified to the latest ISO 9001:2015, AS9100D:2016, and ISO 13485 standards. For additional information, please visit the REDCOM EMS website at www.redcomems.com.
REDCOM Laboratories, Inc., a 2020 Rochester Top Workplace, is a woman-owned small business that specializes in the design and manufacture of advanced tactical and strategic communications solutions with a focus on security, reliability, and interoperability. REDCOM’s customers include all branches of the military, government agencies, emergency responders, integrators, and telecom service providers.