Medical Device Development

Quality Management System

One of the major contributors to PADT Medical’s success in "Engineering Your Medical Device Innovations" is the Quality Management System (QMS) that the team applies to all medical device development projects.  Customers that come to PADT Medical for their medical device product development knowing that they will get world class design, test, and manufacturing services. The also know that the entire process will be conducted under a first rate quality system.

 

 

ISO 13485:2003 Registered

In 2013 PADT obtained a Certificate of Registration for our Quality Management System's compliance with the ISO 13485:2003 Quality Standard.

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.

PADT was audited by Orion Registrar, and will continue to be audited annually to verify continued compliance with the quality standard. 

Designed and Used for Efficiency and Productivity

As with any good quality system, we continually improve our QMS to maintain compliance and improve efficiency.  PADT Medical's QMS covers all of the necessary elements to design, procure, assemble and package a customer's product for clinical use.  This has been a significant advantage to many of the customers who come to PADT Medical for their product development, it often eliminates the need for the customer to develop their own QMS.

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