Navigating FDA and MDR Compliance: Managing the Device Lifecycle and Embedded Software Updates in Medical Devices - Dr. Baya Oussena
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the Medical Device Regulation (MDR), ensure the safety, effectiveness, and quality of medical devices. For software-driven devices, compliance is an ongoing process; each update or modification can present regulatory challenges for manufacturers. The rapid pace of software innovation makes navigating regulations more complex. Proactively addressing these challenges enhances quality, improves reliability and safety, and adds value for both patients and healthcare providers.
Preparing for the U.S Food and Drug Administration (FDA) premarket and 510(k) submissions
Expanded health access with telemedicine and digital health solutions; personalized healthcare and advanced detection and monitoring for improved patient outcomes. Operational efficiencies through automation, digitalization, and entirely new workflows. Promising cutting-edge Internet of Medical Things (IoMT) and AI-powered solutions tackling today's most challenging issues. For the medical and healthcare industry, technology holds massive untapped potential. Yet, it also comes with novel challenges.
Siemens Rail Case Study
With Mender, Siemens Mobile Communications can perform secure and robust remote updates to digital cabin radios on a UK Network Rail train fleet.