Gilero Biomedical Achieves ISO 13485 Certification For Medical Device Design and Development

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Gilero Biomedical, a leading provider of medical device and pharmaceutical delivery device design and development services, announced that the company has received ISO 13485 certification for its quality management system.

Gilero Biomedical, a leading provider of medical device and pharmaceutical delivery device design and development services, announced that the company has received ISO 13485 certification for its quality management system. ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet customer and regulatory requirements for design and development of medical devices.

"The ISO certification is a significant accomplishment and an important milestone for Gilero’s 10th year in business. Certification has been one of our top business priorities because it is important to our customers. It affirms that our Quality Management System meets the highest standards and strengthens Gilero's commitment to product quality and customer service," said Ted Mosler President & CTO.

About Gilero Biomedical
Gilero Biomedical is a full-service pharmaceutical and medical device design and product development company specializing in single-use devices. Their extensive engineering, clinical, and manufacturing experience allows them to design products that effectively combine human factors, manufacturability, and mechanical performance. Gilero Biomedical was formed in 2002 and is located in Research Triangle Park, NC. For more information, please visit the company's website at http://www.gilero.com.

About ISO 13485
ISO 13485:2003 was created by the International Organization for Standardization (ISO) as an international quality management standard for medical devices. ISO 13485:2003 supplements ISO 9001:2000 with additional requirements for the medical industry in the areas of design and process controls, special processes, traceability, record retention and regulatory actions.

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Tim Hopper
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