NEWS
Introduction to Software and AI in Regulated Medical Devices
Software and AI medical device compliance represents one of the most complex and rapidly evolving areas of regulatory science. It requires integration of traditional quality management principles with... ...more
Medtech
May 21, 2026•6 min read
Decision-Making Under Uncertainty
Decision-making under uncertainty is a defining challenge for therapeutic goods startups. Companies must determine when to validate, submit, or scale manufacturing while balancing quality requirements... ...more
Leadership Values ,Medtech
February 26, 2026•5 min read
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
