Digital Innovation - Webinar CD/Transcript

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Digital Innovation: Revolutionizing Device Regulation

Is the explosion in EMRs affecting the regulation of your interconnected medical devices?

Is messaging middleware impacting your ability to comply with FDA requirements for biomedical software?

Are you using outsourced IT vendors instead of in-house expertise?

Are HIPAA and cybersecurity concerns keeping you up at night and forcing you to become BFFs with your risk management team?

It’s pretty clear that digital medical devices are transforming into information appliances connected to information systems, creating tons of new opportunities — and even more challenges.

Join Tim Gee — Principal and Founder of Medical Connectivity Consulting — on Oct. 5 when he’ll provide insight into the regulatory landscape and recommendations for going forward.

This session will:

  • Detail the market trends and government regulations transforming the medical device industry, including the Joint Commission, FDA, and FTC guidance on mobile apps and other digital products
  • Describe the regulatory changes these trends are having on the medical device industry that impact risk management, verification testing and the use of OTS components
  • Present specific tactics and methods, such as proactive internal audits and PDP documentation strategies to minimize this transformation and provide your company with a competitive advantage

Order today and optimize time-to-market and significantly reduce sustaining engineering costs.

  • RA personnel
  • QA/QC personnel
  • Data management and statistics personnel
  • Engineering and design controls teams
  • Risk management specialists
  • Compliance officers

Tim Gee is principal and founder of Medical Connectivity Consulting (MCC). Tim’s practice revolves around workflow automation through the integration of medical devices with information systems, and enabling technologies. MCC provides strategy development, business planning, business development, process optimization, technology selection and product management for vendors serving ambulatory and acute care providers. Needs assessment, solution specification, process reengineering and vendor selection represents MCC’s services for health care providers.