KD&A – Regulatory consultants for Medical and IVD Devices

Australian medical device companies, including IVD companies.

At KD&A we specialise in designing ISO 13485 Quality Management Systems and Technical Files for medical devices and providing support with the TGA Conformity Assessment process.

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Australian importers & distributors

KD&A can guide your organisation in demonstrating TGA regulatory compliance in the most effective way, to reduce the burden on your organisation and the time to market.

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International medical device companies, including IVD companies

KD&A as an expert regulatory consultant, has significant experience with the global regulatory process for medical and IVD devices and can provide a complete medical device solution.

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We are regulatory consultants with a wealth of expertise, having vast consultancy experience in addition to our Managing Director’s origins as a medical device manufacturer. We provide expert medical device regulatory guidance to help launch products and access new markets.

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

Medical device regulatory strategy report and roadmap to market.
ISO 13485 QMS development, maintenance, internal auditing and support including regulator/ Notified Body audits.
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.
Development of device specific Technical File documentation for medical devices and IVD devices.
TGA sponsor services.
Post market surveillance including reporting to the TGA.