Virtual Symposium

Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and some testing is not enough. You should not go to a test facility and ask them what testing should be done. You should have planned, documented, and developed the device knowing what testing would be required. All medical devices need to have a complete, current, and accurate design and development file, connected devices especially so. With multiple subsystems, components, software and interconnectivity to consider, following the design control methodology will help the development team stay organized and on track. We are here to help

As medical devices become increasingly complex and connected, selecting the right sterilization modality is more critical than ever. This session will explore key considerations for choosing the most suitable sterilization technologies for connected devices, balancing efficacy and material compatibility. We will also address packaging design considerations, transportation challenges, and shelf-life validation to ensure product integrity from sterilization to end use.
Split into 3 subsets: Sterilization, Battery, Packaging

Connected devices often feature complex system architectures with multiple components and subsystems, frequently developed by different teams. This session will highlight common pitfalls encountered during the development of connected devices—issues that, if identified too late, can lead to significant timeline delays and resource overruns. Drawing from their extensive experience, the speakers will share key warning signs and practical strategies to mitigate risks, helping you navigate development challenges more effectively.

Biocompatibility is a broad analysis of the overall safety of the device to the patient due to materials and manufacturing processes. An overview of important considerations and regulatory expectations will be provided in this presentation. The assessment of extractables and leachables, which relates to chemical characterization of devices, is an important step in the Biocompatibility Evaluation. This presentation will also give an introduction into the definitions and concepts of extractable and leachable testing. More specifically, a high-level perspective will be given on the regulatory landscape, along with which guidelines should be considered for connected device. A specific case study will give practical example of the different steps involved in these analytical studies.

The assessment of extractables and leachables, which relates to chemical characterization of devices, is an important step in the qualification process to ensure patient safety. This presentation will give an introduction into the definitions and concepts of extractable and leachable testing. More specifically, a high-level perspective will be given on the regulatory landscape, along with which guidelines should be considered for connected device. A specific case study will give practical example of the different steps involved in these analytical studies

This presentation will explore the intersection of Artificial Intelligence (AI) in medical devices and the FDA’s 510(k) premarket notification process. It will highlight and address the challenges posed by the dynamic nature of AI when compared to traditional regulatory frameworks, particularly regarding device modifications and updates. The presentation will also discuss the use and application of Predetermined Change Control Plans (PCCPs) within device submissions. The presentation will highlight how well-defined PCCPs can streamline the regulatory pathway for AI medical devices by proactively outlining anticipated changes and ensuring patient safety and regulatory oversight. Key considerations for developing robust PCCPs will also be discussed, providing practical insights for manufacturers.