PADT Achieves ISO 13485:2003 Certification for Medical Devices

TEMPE, Ariz. - June 20, 2013 - PRLog -- Phoenix Analysis & Design Technologies, Inc. (PADT, Inc. (http://www.padtinc.com/)), the Southwest’s largest provider of simulation, product development, and rapid prototyping services and products, is pleased to announce that they have received a Certificate of Registration for their Quality Management System's compliance with the ISO 13485:2003 Quality Standard.  The registration applies to the application of the quality system to the "Contract Design, Development, Testing, and Manufacturing of Clinical Devices for the Medical Industry."

Rob Rowan, PADT's Director of Engineering pointed out that "When customers come to us with a new medical device idea that they want to develop into a product, they now know that PADT will be carry out that entire process under a quality system that has been rigorously reviewed by an accredited auditing organization."  He added that "they can also be assured that our processes are continuously being evaluated and improved as part of the ISO 13485 standard."

The certification applies to the quality system used by PADT Medical, a group within PADT that focuses on the development of medical devices by applying advanced engineering methodologies to solve difficult development problems, all under an approved quality management system.  PADT has been operating under a quality system since 2006.  However the ISO 13485:2003 certification shows that an outside entity has gone through a rigorous process to ensure that PADT is complying with quality standards that are recognized by the industry and regulatory agencies.

"Operating under ISO 13485 reassures our OEM customers that we can provide them with the rigorous quality and documentation they need" commented Mark Johnson, one of PADT's four owners and the principal-in-charge of Product Development. He added that "Our quality system offers benefits to small companies as well because they can work under our quality system during the startup phase and avoid that cost until they mature. By working with PADT, customers can use our approved quality system, save considerable time and money, and be better prepared to for review from regulatory agencies like the FDA."

PADT was audited by Orion Registrar, and will continue to be audited annually to verify continued compliance with the quality standard.  A copy of PADT's registration certificate can be found at www.padtinc.com/downloads/PADT-ISO-13485-Certificate-Medical-Devices.pdf

Anyone interested in learning more about PADT's registration or medical device development services can contact Rob Rowan at 480.813.4884 or email rob.rowan@padtinc.com.

Phoenix Analysis and Design Technologies, Inc. (PADT) is an engineering service company that focuses on helping customers who develop physical products by providing Numerical Simulation, Product Development, and Rapid Prototyping products and services. PADT’s worldwide reputation for technical excellence and an experienced staff is based on its proven record of building long term win-win partnerships with vendors and customers. Since its establishment in 1994, companies have relied on PADT because “We Make Innovation Work.“  With over 75 employees, PADT services customers from its headquarters at the Arizona State University Research Park in Tempe, Arizona, their Littleton, Colorado office, their new office in Albuquerque, New Mexico, and through staff members located around the country. More information on PADT can be found at www.PADTINC.com.