Medical Device Interoperability Training including Cybersecurity Training
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manu-facturers require that such interoperability is safe. The one day training class will introduce eHealth applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices. This one day session will also provide an overview of topics including mobile medi-cal applications, wireless connectivity, and cybersecurity.
• eHealth, mHealth and the new domain of connectivity • Interoperability and risk – strategies to address safety and security of interconnected devices • Global regulators’ response to interoperability and mobile health, what standards and guidances apply to your products • Strategies for compliance of connected, interconnected and mobile applications
On completion of this course, you will
• Know what the core safety issues related to interoperability that manufacturers, integrators and healthcare providers should consider • Understand the responsibilities of medical device manufacturers, systems integrator and supply chain vendors in managing risk for medical systems • Understand the global regulatory trends and requirements • Have examples of how can manufacturers, designers, and developers can support regulatory claims
Who should attend
• Product safety engineers • Compliance engineers • Product designers • R&D engineers • Software engineers • Technical marketing professionals • Hospital IT administrators • Systems Integrators / Clinical Engineers • Regulatory Affairs professionals
• Date: 12 March 2015 • Cost: £225- Save when you register for both the Medical Device Interoperability & Medical Device Software Training Seminars • Location: The Manor, Huxley Close, Godalming, Surrey GU7 2AS • Register: https://eumedicaldevicesoftwareinteroperabilitytraining.eventbrite.com • For questions contact Laura Elan at [email protected] or T: +1.847.664.2330