NEWS
Case Study SaMD and IVD Medical Device Start-Up
This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness. ...more
Medtech
January 07, 2026•5 min read
How AI Could Replace Animal Testing
AI-driven approaches present a transformative opportunity to reduce or replace animal testing in preclinical drug development. By integrating machine learning, computational biology, and multi-omics d... ...more
Medtech
December 08, 2025•5 min read
Establishing Readiness for Clinical Trial Manufacturing
Establishing readiness for clinical trial manufacturing is a multidimensional process requiring attention to regulatory compliance, facility and personnel preparedness, quality systems, process valida... ...more
Medtech
November 24, 2025•5 min read
Implementing a Robust CAPA System in Therapeutic Goods Manufacturing
A robust CAPA system is fundamental to the quality management of therapeutic goods, biotechnology products, and medical devices. ...more
Medtech ,Compliance
November 12, 2025•5 min read
Who Should Use QSN Academy?
QSN Academy is designed for a broad but clearly defined audience: organisations and individuals who seek to understand, implement, and sustain compliance through critical thinking and scientific appli... ...more
Medtech
October 29, 2025•6 min read
The safe and effective reprocessing for Reusable Medical Devices
By incorporating AS 4381 methodologies into design, manufacturing, and reprocessing validation, organisations enhance both compliance efficiency and product safety. ...more
Medtech
October 22, 2025•7 min read
