Software as a Medical Device (SaaS / SaMD)
Published on: 04/06/2026
Software now performs functions that were historically limited to physical medical devices, laboratory instrumentation, or direct clinical assessment.
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Surge in Data Integrity Findings in GxP Inspections
Published on: 15/04/2026
Recent inspection trends reinforce a fundamental principle: organisations cannot control risks that they cannot see. Data integrity failures, supply chain vulnerabilities, and system fragmentation all point to the same underlying issue—insufficient visibility into the true state of operations.
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TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach
Published on: 03/02/2026
The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods.
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Funding & Investor Expectations
Published on: 20/01/2026
For therapeutic goods, biotechnology, and medical device startups, securing funding is not simply a matter of demonstrating innovative science. Investors require evidence of robust governance, clear regulatory pathways, and effective risk management.
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