HOW SOFTWARE CAN BE LEVERAGED TO STREAMLINE DEVICE DEVELOPMENT

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.