KD&A Pty Ltd The company is a South Australian based company established in early 2004 by Managing Director, Kea Imgraben. Our company provides regulatory advice to medical device and IVD companies selling on Australian and international markets. Kea has a long history in the medical device industry, and first-hand experience developing, manufacturing, marketing, selling and supporting innovative medical products. Since 1996 Kea has worked with regulatory and quality management system requirements in 44 different countries. Prior to establishing the company, Kea lead Dentsleeve Pty Ltd for 10 years, a producer of highly specialised, diagnostic pressure devices for gastroenterology. Kea’s experience with Dentsleeve, along with many clients, has allowed her to have a real-world understanding of the importance of carefully balancing business growth and profitability, with regulatory and compliance requirements. Kea is an active and recognised member of the business community. In 2002 she won the South Australian Telstra Business Woman of the Year (private sector category), and in 2003, she was a State Finalist in the Entrepreneur of the Year Awards. Kea was previously a member of the Strategic Industry Leaders Group for the Medical Devices Action Agenda, and is a member of the Regulatory Affairs Professionals Society (RAPS). In 2009, Philippa Henning joined the company as an Associate. Like Kea, Philippa is pragmatic, efficient and energetic. Philippa’s expertise lie in assisting medical device and IVD companies to obtain regulatory certification, which involves a number of processes dependent on product type (visit our home page for more detail). Philippa has significant experience with the TGA in completing applications for all medical device classes, along with other product types such as listed medicines and other therapeutic goods. With Philippa’s expert guidance, attention to detail and inside knowledge, the sometimes challenging regulatory process becomes straight-forward. In addition, Philippa enjoys maintaining the company website and keeping up to date with the ever-changing regulatory world, and has a keen focus on ensuring the company provide a high level of customer service through streamlined and effective processes. Philippa is also a member of the Regulatory Affairs Professionals Society (RAPS).