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Tag Archives: Regulatory Quality and compliance

Medical Devices: Reclassification framework of certain devices

As of the 25th November 2021, the Therapeutic Goods Administration (TGA) has commenced the implementation of revised medical device framework incorporating reclassifications for some medical devices.  The medical device framework includes new regulatory requirements, to demonstrate the safety and efficacy … Continue reading

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Administrator, Regulatory, Quality & Compliance

About us  Commercial Eyes is the foremost life sciences commercialisation business in Australia and New Zealand. With a team of over 100 people and 20 years of expertise, we have assisted more than 650 pharmaceutical, medical device, diagnostic and consumer healthcare companies.   … Continue reading

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Commercial Eyes Recruiting: Consultant, Regulatory, Quality & Compliance

  The Opportunity The Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand.  The Consultant manages client projects, working closely with other members of the team, to deliver … Continue reading

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Commercial Eyes recruiting: Associate Consultant, Regulatory, Quality & Compliance

    The Opportunity The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of a range of regulatory … Continue reading

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New TGA framework to redefine personalised medical devices

This post will cover the recent changes brought to regulation of personalised medical devices, under a new TGA framework. Continue reading

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