Sales: 317-960-4220
FREE ON-DEMAND WEBINAR 

HOW SOFTWARE CAN BE LEVERAGED TO STREAMLINE DEVICE DEVELOPMENT

Watch the Free Webinar

 

There are many opportunities for reducing time to market in device development.

A trend that began with electronic data capture (EDC) systems in the early 2000s, automating manual processes using SaaS applications can save measurable amounts of time and money.

Such cloud-based software can enhance quality and standardization, and we expect to see more of it in the clinical and regulatory space looking forward.

In this free 60 minute webinar our presenter Elizabeth FitzGerald, Director, Regulatory Intelligence at Right Submission, will discusses how software can be leveraged to streamline device development. 

 

SPECIFICALLY, YOU WILL LEARN:

  • Discussion of the evolution of EDC systems, and while they took time to be fully accepted/adopted, why they are now the gold standard in clinical trials data management.
  • The importance of other innovative software (i.e., RIM systems, Greenlight Guru, and Right Submission) and the opportunities they hold to promote efficiencies and accuracy for the regulatory submission process.
  • Time and cost savings associated with software in the medical device industry.
  • How FDA’s recent commitment to prioritize Patient Reported Outcomes in assessing effects of medical devices offers further opportunities for new software and mobile applications to collect real-time PROs that seamlessly integrate with existing software platforms.

Who should attend?

  • Medical Device Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • Clinical Affairs Professionals and Management 

  • R&D Engineers and Management

 

About the presenter:

Elizabeth has a strong background in preparing regulatory filings pursuant to FDA data standards, with experience developing software applications and EDC systems for FDA-regulated companies.

She has a Bachelor’s degree in English from Penn and a Master’s degree in Health Communications from Harvard's School of Public Health.


Presenter

 liz-fitzgerald-round

Elizabeth FitzGerald
Director, Regulatory Intelligence
Right Submission

Moderator

 

jon-round-new

Jon Speer
Founder & VP QA/RA
Greenlight Guru

greenlight-guru-logo

About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,

Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.


 

right_submission.png
About RIGHT SUBMISSION

Right Submission changes the way biotechnology companies handle regulatory applications. Their validated, customizable, SaaS tools guide teams through collaborative submission generation from start to finish. These tools, designed by a team of experienced regulatory consultants, streamline the regulatory submission process to ensure accuracy and completeness, thereby achieving FDA clearance faster. Click here to learn more.

 

FEATURED IN