2022 Executive Certificate Workshop: Regulation of Software as a Medical Device (Conducted Face-to-Face)

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.


Date and Time

25 Oct 2022 @ 08:30 - 26 Oct 2022 @ 17:30


Registration is closed


Jason Lim 2022
Mr Jason Lim LinkedIn

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


Mr Andrew Wu LinkedIn

General Manager
Lead Software Consultant 
Rook Quality Systems 


Mr Allen Chen LinkedIn

Senior Software Quality Engineer
Project Manager
Rook Quality Systems

Paul Chua

Mr Paul Chua 

Cybersecurity Group
Digital Health
APACMed & Cybersecurity Officer
Greater Asia BD

Monir El Azzouzi
Mr Monir El Azzouzi LinkedIn

Founder & CEO
Easy Medical Device

Nichol Lim

Mr Nichol Lim LinkedIn

Head of Consulting
Stendard, ISO SMART Champion (APAC)

Lesley Maloney

Dr Lesley Maloney LinkedIn

Regulatory Policy Lead - Digital Health
International Regulatory Policy
Product Development Regulatory

Maria C Matienzo

Ms Maria Cecilia C Matienzo

Director IV
Center for Device Regulation
Radiation Health, and Research
Food and Drug Administration

Aufar Rahadiandy

Mr Aufar Rahadiandy LinkedIn

Country Manager
Stendard, ISO SMART Champion (APAC)


Mr Roland ShumLinkedIn

Software Engineer
Software Consultant
Rook Quality Systems

John Thornback

Dr John ThornbackLinkedIn

Senior Advisor
DxD Hub 


Dr Reni Yohannan 

Quality Engineer
Rook Quality Systems