About

KD&A is an Australian based consulting firm established in 2003 by Managing Director, Kea Dent.

KD&A specialise in providing a range of medical device regulatory services to manufacturers, sponsors and distributors of medical devices and IVD devices. These services include:

  • Medical device Regulatory Strategy Report and roadmap to market.
  • ISO 13485 QMS development, maintenance, internal auditing and support, including regulator/Notified body audits.
  • Development of Device Specific Technical File documentation for medical devices and IVD devices.
  • Global medical device registrations; EU CE marking, Australia TGA Conformity Assessment and Australian Register of Therapeutic Goods (ARTG) Inclusions, US FDA, Health Canada, UK UKCA, Singapore HSA, etc.
  • Post market surveillance including reporting to the TGA.
  • Promotional Materials Review
  • TGA sponsor services.
  • Device Classification Assessment

KD&A offers efficient and practical regulatory solutions to medical device manufacturers, legal representatives, and distributors in different markets around the world. KD&A has supported over 480 companies navigate product certifications such as CE Marking defined in Medical Device Directive (MDD) 93/42/EEC (now superseded)/Medical Devices Regulation (EU) 2017/745, TGA conformity assessment and ARTG inclusions, FDA 510(k), Health Canada certifications, UK UKCA, Singapore HSA, QMS ISO 13485/MDSAP and many other certifications.

KD&A also support organisations to meet QMS ISO 13485/MDSAP requirements through providing QMS creation, implementation, and maintenance services.

Kea Dent

With over three decades of experience in the medical device sector, Kea possess a wealth of expertise, having worked as both a medical device manufacturer and regulatory consultant. Kea’s journey commenced in 1993 when she setup and managed a medical device manufacturing business. Over the subsequent decade Kea navigated the medical device regulatory landscape firsthand 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) clearance, TGA and Health Canada certifications, etc.) and QMS certifications crucial for market access to over 44 countries.

In 2003, the manufacturing business was sold to a Canadian competitor, allowing Kea to build KD&A into a successful regulatory consulting business. Kea’s personal success is displayed through her 2002 selection as the winner of the South Australian Telstra Business Woman of the Year Award in the private sector category.

Kea is equipped with a breadth of knowledge on medical device product development and life cycle requirements globally. Her expertise is exemplified through her Regulatory Affairs Certification (RAC), with the Regulatory Affairs Professionals Society (RAPS).

Bibiana Franco

Bibiana, Senior Associate, has been an integral part of KD&A since 2012. Bibiana’s work ethic 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 Pirauo

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.

Mya Imgraben

Joining KD&A in 2022, Mya works in a position which encompasses both social media management and office assistance. In her role, she is responsible for curating and executing strategic content through Linkedin, effectively raising awareness about the latest regulatory standards and how they impact the medical device industry. Additionally, Mya ensures the smooth operation of the office, providing vital administrative support, managing schedules, and assisting with client communications.

Charlie

Charlie, the Office Dog at KD&A, plays a key role in boosting morale and reducing stress. With a knack for greeting everyone warmly, she makes our office a more welcoming and relaxed place for team members and visitors alike.