KD&A is an Australian based medical device and IVD consulting firm established in 2005 by Managing Director, Kea Dent. KD&A provides expert regulatory consulting services 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 KD&A, Kea led Dentsleeve Pty Ltd for 10 years, a producer of highly specialised, diagnostic pressure devices for gastroenterology.
Kea’s experience with Dentsleeve, along with her medical device consulting experience for a vast number clients over the last 26 years, has allowed her to have a real-world understanding of the importance of carefully balancing business growth and profitability, with medical device and IVD mandatory regulatory compliance.
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. Her achievements include obtaining many global regulatory certifications such as CE mark (European Union), Food and Drug Administration 510(k) clearances (USA), Health Canada (Canada). TGA certifications (Australia), European Medicines Agency (EMA) and Medicines and Healthcare Products (MHRA, United Kingdom) approvals. She has also created, implemented and maintained numerous quality management systems certified to ISO 13485.
Kea has collaborated as a consultant, along the years, with government departments and industry groups such as, the Strategic Industry Leaders Group for the Medical Devices Action Agenda, the Therapeutic Goods Administration (TGA), and the Regulatory Affairs Professionals Society (RAPS) to facilitate regulatory compliance processes for manufacturers around the world. Her expertise is exemplified through her Regulatory Affairs Certification (RAC), through RAPS. This has equipped Kea with a breadth of knowledge on medical device product development and life cycle requirements, US FDA requirements, EU regulations and globally applicable regulatory practices.
Bibiana, Senior Associate, joined KD&A in 2012. Bibiana’s work ethics and high standard of quality service, proved a perfect match with KD&A’s vision. Bibiana’s expertise lie in assisting medical device and IVD companies to obtain regulatory certification, which involves a number of processes dependent on the product type (visit our Services page for more detail).
Bibiana has great knowledge of the regulatory requirements for medical devices and IVDs and works with regulation on a daily basis to ensure KD&A clients have a smooth path to market in Australia. Bibiana’s can do attitude, attention to detail and understanding of the medical device regulations across the different markets ensures she is a highly skilled medical device and IVD consultant who provides KD&A clients with efficient and effective regulatory compliance solutions.
Louise joined KD&A in February 2021 as an Associate with over 15 years practical experience in the industry. She has held leadership roles in Operations before moving into quality and regulatory compliance specific roles, meaning she has hands-on experience across the entire medical device life cycle including design and development activities, ensuring product conformity and training. Louise has extensive knowledge in global regulatory requirements across a range of device classifications for CE Marking (European Union), Food and Drug Administration (FDA, United States), Food and Drug Administration Thailand, Health Canada and TGA (Australia). This includes internal and external audits against a range of regulations including AU TGA PIC/s guidelines, EN ISO 13485:2016, EU MDD 93/42/EEC, EU MDR 2017/745, MDSAP and US FDA 21CFR820.
Louise is very familiar with Quality Management Systems (QMS) implementation and maintenance across a range of platforms. Her practical industry experience, positive attitude, attention to detail and ability to effectively problem solve ensure she provides KD&A clients with regulatory solutions focused on compliance while meeting individual commercially focused needs.