In today’s digital world, technologies and software play an increasingly important role in healthcare management - diagnosis, treatment, patient monitoring and utility of Real World Evidence. Some of these innovative technologies include softwares and health applications that either work independently or support a medical device. The unique features of these Software as Medical Device (SaMD) set the differentiation on how it should be regulated compared to traditional medical devices. This course aims to provide a better understanding of the regulations for SaMD, including requirements for safety assessments, that will aid in the development, market entry and utility of SaMDs.
Due to the limited availability of seats, early registration is strongly recommended.
Click here to find out more about the Fees.
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.
Should the event be conducted online, please provide your CPE/CME number in the respective e-registration form.
The attendee’s registration details will be submitted after the event and credited upon receiving respective approvals.
Date and Time
25 Oct 2022 @ 08:30 - 26 Oct 2022 @ 17:30
Speaker

Mr Jason Lim 
CEO and Co-Founder
Stendard, ISO SMART Champion (APAC)

Mr Andrew Wu 
General Manager
Lead Software Consultant
Rook Quality Systems

Mr Allen Chen 
Senior Software Quality Engineer
Project Manager
Rook Quality Systems

Mr Paul Chua
Vice-Chairman
Cybersecurity Group
Digital Health
APACMed & Cybersecurity Officer
Greater Asia BD

Mr Monir El Azzouzi 
Founder & CEO
Easy Medical Device

Mr Nichol Lim 
Head of Consulting
(Singapore)
Stendard, ISO SMART Champion (APAC)

Dr Lesley Maloney 
Regulatory Policy Lead - Digital Health
International Regulatory Policy
Product Development Regulatory
Genentech

Ms Maria Cecilia C Matienzo
Director IV
Center for Device Regulation
Radiation Health, and Research
Food and Drug Administration
Philippines

Mr Aufar Rahadiandy 
Country Manager
(Indonesia)
Stendard, ISO SMART Champion (APAC)

Mr Roland Shum
Software Engineer
Software Consultant
Rook Quality Systems

Dr John Thornback
Senior Advisor
DxD Hub

Dr Reni Yohannan
Quality Engineer
Rook Quality Systems
Venue