DeviceLab Gets ISO 13485 Certification
Verifies Best Practices for Medical Device Development Quality Management
Tustin, CA, January 25, 2012 --(PR.com)-- DeviceLab Inc., an Orange County medical product design and product development company, today announced that it has received ISO 13485 certification from the International Organization for Standardization.
ISO 13485 is an internationally recognized standard developed to ensure that a medical device design company develops and manufactures medical devices that meet specific quality requirements. More specifically, it is a Quality Management System (QMS) standard specifically developed for the manufacture of medical devices.
The standard contains specific requirements for medical device manufacturing, installation and servicing, including:
* Implementation of a Quality Management System (QMS) with several enhancements
* Risk Management approach to medical product development and product realization
* Validation of processes
* Compliance with statutory and regulatory requirements
* Effective product traceability and recall systems
"ISO 13485 certification is proof of DeviceLab's commitment to quality," said DeviceLab founder and CEO Dac Vu. "This certification aligns DeviceLab's management system to the requirements of the FDA's Quality System Regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world."
Vu said that DeviceLab currently has two active medical device design projects that are being developed under the auspices of ISO 13485, and expects more projects to soon be launched.
"DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing," said Vu. "We look forward to leveraging our new ISO 13485 to provide our unique suite of medical device development services in the coming months and years."
About ISO
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.
ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.
ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.
For more information about ISO, please visit http://www.iso.org.
About DeviceLab
DeviceLab is a contract medical device design and product development firm in Orange County, California.
A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. The company has considerable experience in design and development of tabletop and hand held devices, custom medical carts, hospital equipment and lab instrumentation development.
For more information about DeviceLab, please visit http://www.devicelab.com.
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ISO 13485 is an internationally recognized standard developed to ensure that a medical device design company develops and manufactures medical devices that meet specific quality requirements. More specifically, it is a Quality Management System (QMS) standard specifically developed for the manufacture of medical devices.
The standard contains specific requirements for medical device manufacturing, installation and servicing, including:
* Implementation of a Quality Management System (QMS) with several enhancements
* Risk Management approach to medical product development and product realization
* Validation of processes
* Compliance with statutory and regulatory requirements
* Effective product traceability and recall systems
"ISO 13485 certification is proof of DeviceLab's commitment to quality," said DeviceLab founder and CEO Dac Vu. "This certification aligns DeviceLab's management system to the requirements of the FDA's Quality System Regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world."
Vu said that DeviceLab currently has two active medical device design projects that are being developed under the auspices of ISO 13485, and expects more projects to soon be launched.
"DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing," said Vu. "We look forward to leveraging our new ISO 13485 to provide our unique suite of medical device development services in the coming months and years."
About ISO
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.
ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.
ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.
For more information about ISO, please visit http://www.iso.org.
About DeviceLab
DeviceLab is a contract medical device design and product development firm in Orange County, California.
A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. The company has considerable experience in design and development of tabletop and hand held devices, custom medical carts, hospital equipment and lab instrumentation development.
For more information about DeviceLab, please visit http://www.devicelab.com.
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Contact
DeviceLab Inc.
Lloyd Roberts
+1-714-442-2446
www.devicelab.com
Lloyd Roberts
+1-714-442-2446
www.devicelab.com
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