It is a requirement that all medical devices and IVDs included on the ARTG be monitored whilst on the Australian market. Post-market monitoring is a combination of proactive and reactive actions, and is a mandatory regulatory requirement.
KD&A, as an expert medical device and IVD consultant, has designed a Post Market Surveillance system that will guide your organisation in the process of completing post-market actions such as product reporting, recall, and review. KD&A’s Post Market Surveillance system is tailored to your needs and it will comply with the regulatory requirements applicable to your organisation.
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