Design and Development
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.
- Total product life cycle (TPLC), guidelines and standards for IVD and SaMD
- Project management with specific focus on scoping, resources and project planning
- Concept development, design optimization and design freeze
Validation and Verification
Manufacturing and Quality Management System