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2023 Executive Certificate Workshop: Design and Development (Conducted Face-to-Face)

In Vitro Diagnostic (IVD) and Software as Medical Device (SaMD) product development involves adherence to specific steps to ensure compliance to standards and regulatory requirements to safeguard the health and safety of patients when used. It is important to follow the appropriate steps as it determines the success of regulatory approvals, product launches and product continuity in the market. Broadly, IVD and SaMD product development journey starts with Design and Development after establishing a potential fulfilment of an unmet clinical need. It is during the design and development process that the total product life cycle of a specific medical device is identified that includes subsequent decommissioning or disposal. This first workshop aims to provide a thorough understanding of Design and Development stage and the appropriate processes that need to be followed in there.

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




Date and Time


20 Feb 2023 @ 08:30 - 21 Feb 2023 @ 17:30

Speaker


chan-yang-sun
Ms Chan Yang Sun LinkedIn

Quality Assurance & Regulatory Affairs
Diagnostics Development Hub 

Lijoy George

Mr Lijoy George

Assistant Vice President
Digital Health
Diagnostics Development Hub 

Lin You Bin
Dr Lin You Bin LinkedIn

Senior Manager
Biomedical Project
Diagnostics Development Hub 

Ho Yuan Lu
Ms Ho Yuan Lu LinkedIn

Vice President
Outreach & Talent Development
Diagnostics Development Hub 
  

Rahul Pandey
Dr Rahul Pandey LinkedIn

Outreach & Talent Development
Diagnostics Development Hub 

henry-johnson

Mr Henry Johnson Susainathan 

Senior Manager
Diagnostics Development Hub 

Tan Hwee Ee
Ms Tan Hwee Ee LinkedIn

Founder and Director
DH RegSys Private Limited

John Thornback
Dr John Thornback LinkedIn

Senior Advisor
Diagnostics Development Hub

Venue