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.
Our services include: product registration for Australian (Therapeutic Goods Administration (TGA) Certification), European Union (CE Marking), United States (FDA), and Canadian markets amongst others. We specialise in creating and implementing Quality Management Systems and assist with ISO and Good Manufacturing Practice (GMP) quality system compliance. Our vast understanding of the medical device regulations across the different markets ensures you receive the most accurate and up to date information for your medical and IVD devices.
Visit our website or email us at [email protected] to find out how KD&A can support your business.
Company’s Keywords:
australian medical device regulation regulatory advice, product registration, tga conformity assessment, regulatory strategy, quality management system, post market surveillance system, technical documentation development, product materials review
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medical devices
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