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.

Poster

Programme

Fees

 Click here to find out more about the 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.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.