Sustained Medical Device Regulation Compliance
Ensure Your Regulatory Processes and Tools are Fully Optimized

A Free FDAnews Webinar • Sponsored by Instem
Wednesday, May 20, 2020 • 1:30 p.m. - 2:30 p.m. EDT

Regulatory information is a critical enterprise asset.

Even though the date of application for EU-MDR has been postponed by one year, the medical device industry should not curtail compliance-readiness activities.

Now is the time to challenge the status quo and leverage technology solutions to improve the efficiency of regulatory operations information management. A robust regulatory information management (RIM) software solution will enable your teams to meet the needs of evolving global regulations.

Attend this free webinar sponsored by Instem and understand how to optimize your processes and tools to ensure that your regulatory operations can help get new products to the global market with improved speed, efficiency, productivity, and quality while also ensuring continued regulatory compliance and life-cycle management of your legacy device portfolio.

Kim Young, Instem’s Director, Global Regulatory Intelligence, and Chris Nichols, an Instem Application Specialist, will explain the critical steps of confirming your EU-MDR readiness and remaining compliant with the new upcoming regulation. They’ll share how RIM software can reduce several weeks of manual efforts into just a few hours — if not minutes.

Webinar Takeaways:

  • How your challenges are contrary to the way regulatory teams have traditionally operated across the industry… and how to overcome them
  • How to integrate the critical aspects of EU-MDR compliance
  • How to use the best-possible approaches at each step of the gap analysis
  • What you must consider when deploying a sustainable EU-MDR compliance framework
  • How to avoid challenges and setbacks when searching for the right technology and tools
  • How technology is optimizing some of the largest regulatory operations teams by helping them allocate and rationalize their efforts between rote tasks and business-critical strategic endeavors
  • How to Developing a sustainable cadence to meet global compliance requirements will require a serious modernization effort of processes, technologies and tools

Employ the best-of-breed RIM technologies and you’ll be better equipped to manage the growing volume and complexity of regulatory information, improve your team’s efficiency and quality of work, reduce operating costs, while allowing regulatory affairs staff to focus on strategic initiatives. Join us for this free webinar by registering today.

Who Will Benefit

  • Vice Presidents for Regulatory Affairs
  • Directors for Regulatory Affairs
  • Regulatory Affairs Managers
  • Regulatory Affairs Specialists
  • Regulatory Affairs Project Managers
  • Quality Assurance Managers/Directors
  • IT Directors
  • IT Managers

Sign Up for FREE Below

Meet Your Presenters

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Kim Young

Director, Global Regulatory Intelligence at Instem

Kim Young, Instem’s Director, Global Regulatory Intelligence, is a 20-year regulatory affairs professional. As Instem’s subject matter expert, she is responsible for monitoring market dynamics and ensuring key requirements are an integral part of Instem’s product strategy and development activities. Ms. Young has held key regulatory operations roles across the medical device, pharmaceutical and personal care product industries. She received a Graduate Certificate in Medical Devices and MSc in Regulatory Affairs, Drugs, Biologics and Medical Devices from Northeastern University.

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Chris Nichols

Application Specialist at Instem

Chris Nichols, a 15-year veteran of life sciences and regulatory affairs spanning preclinical through late stage clinical, is a Application Specialist at Instem. In this role, he works closely with organizations to understand their unique regulatory requirements and helps implement Instem’s beneficial solutions. Mr. Nichols received a BS in computer science from Iowa State University and a Masters in Business Administration from the University of St Thomas.