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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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RAPS Focus
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Networking Opportunity
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Ticketed Event
Student Focus
Student Focus

Kea Dent, MBA, GAICD, RAC (she/her/hers)

Director
KD&A
Balgowlah Heights, New South Wales, Australia

In 2003, Kea established KD&A, an Australian based consulting firm offering medical device regulatory solutions for manufacturers, sponsors, legal representatives, and distributors around the world. As a regulatory and Quality Management System (QMS) specialist for medical devices and IVDs, her expertise lies in obtaining TGA and global regulatory product certifications, ISO 13485/MDSAP QMS creation, implementation, certification, maintenance, and regulator audits.

With over three decades of experience in the medical device sector, Kea has worked as both a medical device manufacturer and regulatory consultant. Her career commenced in 1993 when she setup and managed a medical device manufacturing business. Over the subsequent decade Kea gained experience navigating the medical device regulatory landscape first-hand as a device manufacturer, acquiring and upholding numerous product certifications (CE Marking as per the Medical Device Directive 93/42/EEC (obtained in 1998), 510(k), TGA and Health Canada certifications, etc.) and QMS/MDSAP certifications crucial for market access to over 44 countries.

In 2003 the 95% export medical device manufacturing business was sold to a Canadian competitor. Kea's personal success has be awarded through my 2002 selection as the winner of the South Australian Telstra Business Woman of the Year Award in the private sector category. Some other achievements of hers include supporting over 480 companies through the medical device and QMS ISO 13485/MDSAP certification process, including advising and reporting to boards on global strategies, as well as being instrumental in creating and implementing regulatory strategies to enable CE marking as per the Medical Device Directive (MDD) 93/42/EEC (now superseded)/Medical Devices Regulation (EU) 2017/745, TGA conformity assessment and ARTG inclusions, MDSAP, FDA 510(k), Health Canada, UK UKCA, Singapore HSA, and many other medical device certifications.

Presentation(s):

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