KD&A Pty Ltd

medical devices

About

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.

Technologies

ZoneEdit Outlook Canva AI

Keywords

technical documentation development tga conformity assessment australian medical device regulation regulatory advice quality management system product registration regulatory strategy post market surveillance system product materials review medical equipment manufacturing product certification fda clearance distribution regulatory advice regulatory audit support regulatory strategy report compliance management regulatory consulting australia tga regulatory training medical device compliance software as a medical device (samd) regulatory guidance mdsap maintenance eu ce marking b2b global registration software as a medical device regulatory audit preparation regulatory pathway planning ce marking

Location

Manly, New South Wales, Australia, 2095

Related Companies

Companies in the same industry