Regulatory consultants for Medical and IVD devices

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Product Registration »

Expert assistance on the application to include your medical device or IVD in the Australian Register for Therapeutic Goods (ARTG).

Regulatory Strategy »

As experts on medical device and IVD regulation, KD&A can provide you with detail on the regulatory requirements in order to map your road to market.

Quality Management System »

KD&A has vast experience in developing quality management systems for medical device manufacturers. Our expertise will ensure ongoing compliance with the medical device regulations.

Technical Documentation »

As medical device and IVD regulatory experts, KD&A specialises in meeting the regulatory requirements, which include the development of Documentation to comply with the medical device regulations.

TGA Conformity Assessment/CE Mark »

This is the Australian medical device certification process. KD&A will provide you with expert guidance from beginning to end.

Post-Market Surveillance »

KD&A's Post-Market Surveillance system is designed to guide your organisation to comply with the monitoring and product recall requirements of the medical device regulations.

Promotional Materials Review/CE Marking »

KD&A as experts of the medical device regulations can assist you to ensure regulatory compliance with the Australian Therapeutic Goods Advertising Code (TGAC).

We are regulatory consultants who provide expert medical device and IVD regulatory guidance to help launch products and access new markets.
Services include general regulatory advice to product registration in order to access different markets including Australian (TGA), EU (CE Marking), United States (FDA) and Canada.

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Latest News more »

The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers? more »
Important Changes in the Regulatory Framework for IVDs more »
One submission for multiple markets a future reality? more »