1 Main St, Eastwood, SA 5063
KD&A Pty Ltd, Eastwood, SA
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Description
Expert medical device and IVD regulatory guidance to help launch products and access new markets. Services include: product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance.
Company description
KD&A is a South Australian based company established in early 2004 by Managing Director, Kea Imgraben. KD&A 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 KD&A, 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.
Categories & Keywords
- Mammography