Whiteley Corporation recently obtained Medical Device Single Audit Program (MDSAP) certification that will allow it to directly export Medical Devices into both the USA and Canada.

Whiteley’s products are now certified to leave from their hunter-based manufacturing location of Tomago in the Hunter Region of NSW, directly to the US and Canadian Healthcare markets. This will allow Whiteley to expand and grow hunter-made products globally, while still providing demand nationally.

Darran Leyden, Whiteley Managing Director stated “Whiteley have been licensing our Medical technology to other companies in North America for decades. This new Quality Certification allows us to directly supply into the US and Canadian Healthcare markets straight out of the Hunter which is an exciting growth step for our company.”

MDSAP is a program that was established by a group of individual countries medical regulators who aimed to streamline the requirements for getting Quality Management System certifications for international companies. The single audit has two primary objectives - avoid duplication of regulatory resources across multiple countries and minimize disruptions of medical device manufacturers from multiple regulatory audits.

Darran Leyden added “This has been a huge effort from our Regulatory Team and our staff across the board and further strengthens our Quality System so customers can be certain our products comply with regulatory standards in multiple countries.”