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.
Programme Overview
- 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
Regulatory compliance is a necessity in the development of medical devices such as In Vitro Diagnostic (IVD) and Software as Medical Device (SaMD) to safeguard the health and safety of patients when used as intended. This is pivotal to an effective product life cycle management.
This workshop will build upon concepts on Design and Development and look into how manufacturing requirements are determined. These procedures are essential to ensure that products developed during the design phase can be manufactured, and contribute to the successful planning of product registration activities.
Programme Overview
- 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
Manufacturing and Quality Management System
With the many processes and regulatory requirements for In Vitro Diagnostic (IVD) and Software as Medical Device (SaMD) products, it is a challenging task for any company to ensure compliance. This is a risk to both the public as well as the company, and thus it is crucial to have a system that effectively oversees these processes in maintaining the quality of products. In this workshop, hear from experts who will be discussing about manufacturing requirements, including quality management system requirements, as well as the regulatory steps necessary for a company to release the product for sale in regulated markets.
Programme Overview
- Gain deeper insights in the processes to ensure the robustness and reliability of manufacturing procedures following the registration and launch of a new product.
- Learn about the regulatory steps necessary to allow a product to be released successfully into the market.
- Acquire knowledge on the importance of a well-documented Quality Management System (QMS) and its successful implementation.