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
![Jason Lim 2022 Jason Lim 2022](/images/librariesprovider5/default-album/jason-lim-2022.tmb-thumbnail.png?Culture=en&sfvrsn=89da59f5_1)
Mr Jason Lim ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
CEO and Co-Founder
Stendard, ISO SMART Champion (APAC)
![Andrew_Wu Andrew_Wu](/images/librariesprovider5/default-album/andrew_wu.tmb-thumbnail.jpg?Culture=en&sfvrsn=5c09c6d1_2)
Mr Andrew Wu ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
General Manager
Lead Software Consultant
Rook Quality Systems
![Allen_Chen Allen_Chen](/images/librariesprovider5/default-album/allen_chen.tmb-thumbnail.jpeg?Culture=en&sfvrsn=54eee426_1)
Mr Allen Chen ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Senior Software Quality Engineer
Project Manager
Rook Quality Systems
![Paul Chua Paul Chua](/images/librariesprovider5/default-album/paul-chua-bio-photo-2019.tmb-thumbnail.jpg?Culture=en&sfvrsn=6850ca7a_3)
Mr Paul Chua
Vice-Chairman
Cybersecurity Group
Digital Health
APACMed & Cybersecurity Officer
Greater Asia BD
![Monir El Azzouzi Monir El Azzouzi](/images/librariesprovider5/default-album/monir-el-azzouzi.tmb-thumbnail.jpg?Culture=en&sfvrsn=16574e2d_1)
Mr Monir El Azzouzi ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Founder & CEO
Easy Medical Device
![Nichol Lim Nichol Lim](/images/librariesprovider5/default-album/nichol-lim.tmb-thumbnail.jpeg?Culture=en&sfvrsn=909a0256_1)
Mr Nichol Lim ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Head of Consulting
(Singapore)
Stendard, ISO SMART Champion (APAC)
![Lesley Maloney Lesley Maloney](/images/librariesprovider5/default-album/lesley-maloney.tmb-thumbnail.jpg?Culture=en&sfvrsn=99863c44_1)
Dr Lesley Maloney ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Regulatory Policy Lead - Digital Health
International Regulatory Policy
Product Development Regulatory
Genentech
![Maria C Matienzo Maria C Matienzo](/images/librariesprovider5/default-album/maria-c-matienzo.tmb-thumbnail.png?Culture=en&sfvrsn=f17b07ef_1)
Ms Maria Cecilia C Matienzo
Director IV
Center for Device Regulation
Radiation Health, and Research
Food and Drug Administration
Philippines
![Aufar Rahadiandy Aufar Rahadiandy](/images/librariesprovider5/default-album/aufar-rahadiandy.tmb-thumbnail.png?Culture=en&sfvrsn=f8849bda_1)
Mr Aufar Rahadiandy ![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Country Manager
(Indonesia)
Stendard, ISO SMART Champion (APAC)
![Roland_Shum Roland_Shum](/images/librariesprovider5/default-album/roland_shum.tmb-thumbnail.jpeg?Culture=en&sfvrsn=ecc36a62_1)
Mr Roland Shum![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Software Engineer
Software Consultant
Rook Quality Systems
![John Thornback John Thornback](/images/librariesprovider5/people/john-thornback.tmb-thumbnail.jpg?Culture=en&sfvrsn=b2c0283_1)
Dr John Thornback![linkedIn_button LinkedIn](/images/librariesprovider5/events/etc/linkedin_button.png?sfvrsn=2de01fc1_0&MaxWidth=18&MaxHeight=18&ScaleUp=false&Quality=High&Method=ResizeFitToAreaArguments&Signature=1576CF075402B7F6AE3A36EE2D0F1E476E6AFE0B)
Senior Advisor
DxD Hub
![Reni_Yohannan Reni_Yohannan](/images/librariesprovider5/default-album/reni_yohannan.tmb-thumbnail.jpg?Culture=en&sfvrsn=a3030872_1)
Dr Reni Yohannan
Quality Engineer
Rook Quality Systems
Venue