4 Units

In today’s digital world, technologies and software play an increasingly important role in healthcare management - diagnosis, treatment, patient monitoring and Real World Data collection. While software-based medical devices products are currently controlled via medical device regulation, they differ significantly from traditional medical devices requiring a more streamlined and efficient regulatory oversight. Software standards and guidelines published by standards development organisations (eg., ISO, IEC) and regulatory agencies/forums are important tools for effective governance for safe, quality and efficacious health products and timely access for patients.

This course provides the foundation in understanding established standards, guidelines and regulatory principles on conformity assessment of medical device softwares.