NEWS
Software as a Medical Device (SaaS / SaMD)
Software now performs functions that were historically limited to physical medical devices, laboratory instrumentation, or direct clinical assessment. ...more
News
June 04, 2026•6 min read
Surge in Data Integrity Findings in GxP Inspections
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... ...more
News
April 15, 2026•6 min read
We specialise in training for start ups
Start up organisations in regulated life science industries operate in complex and rapidly evolving environments where scientific innovation must be balanced with regulatory compliance. Structured tra... ...more
News
April 01, 2026•5 min read
TGA Compliance Principles 2026–2027: A Proactive and Risk-Based Approach
The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods. ...more
News
February 03, 2026•5 min read
Funding & Investor Expectations
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 r... ...more
News
January 20, 2026•4 min read
Explore Complimentary Training Courses at QSN Academy
For therapeutic goods manufacturers, testing laboratories, and biotechnology companies, engaging with QSN Academy’s complimentary courses represents a strategic investment in personnel development, op... ...more
Quality Training ,News
January 03, 2026•5 min read
