Qualtech Webinar: Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial – July 2025

• 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

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USA: NEW STANDARDS RECOGNITION TO SUPPORT INNOVATION IN MEDICAL DEVICE STERILIZATION — AUGUST/SEPTEMBER 2023

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

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A Reformed Examination and Approval System of CFDA to Promote Drug and Medical Device Development and Innovation - October, 2017

• 2020-02-15 06:26:28

On October 8, the General Office of the CPC Central Committee and the General Office of the State Council issued "the Reformed Examination and Approval System of CFDA to Promote Drug and Medical Device Development and Innovation", and required all localities and departments to implement.

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