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

Due to the limited availability of seats, early registration is strongly recommended.

Click here for a step by step guide on how to register.

Programme

TBC 

Fees

 

Click here to find out more about the Course Fees.

Continuing Education Credits

The Centre of Regulatory Excellence is an accredited provider for Continuing Professional Education (CPE) for Pharmacists and Continuing Medical Education (CME) for Doctors.

Continuing education credits are available for CoRE events through the Singapore Pharmacy Council and the Singapore Medical Council subject to their respective approvals. 

Attendees who wish to avail of the credits are required to sign the relevant registration form along with their CPE/CME number on the day of the events.

The attendee’s registration details will be submitted after the event and credited upon receiving respective approvals.