Services

REGULATORY CONSULTING SERVICES TO HELP YOU LAUNCH PRODUCTS AND ACCESS NEW MARKETS

As expert medical device consultants, KD&A provides you with sound regulatory advice that will save you money and time as you prepare medical devices and IVDs for market launch. KD&A will help you understand early on which regulatory requirements apply, so you can plan ahead to meet requirements cost-effectively and with minimal disruption.

KD&A provides expert regulatory consulting services to help you launch medical devices and IVDs, and access new 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.

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