How Terumo Reg Affairs leverages Essenvia

Terumo Medical Corp has been one of the world’s leading manufacturers of medical devices and supplies responding to the needs of patients and healthcare professionals since 1921. By relentlessly pursuing excellence Terumo contributes to society in more than 160 countries around the world.

Before Essenvia RIMS AI

With over 40,000 critical regulatory artifacts like submissions, licenses and registration records stored across multiple non-validated systems used for information storage and handling and multiple points of contact limiting efficient information access and sharing. The other RIMS solutions were difficult to use and hard to implement.

Terumo needed a centralized solution to organize and index their regulatory data and simplify their regulatory workflows -- supporting growth in compliance requirements. Other RIMS solutions they tried were complex to use and very hard to implement.

That’s why they turned to Essenvia.

With Essenvia

Accelerating critical regulatory processes - simplifying day-to-day work and faster response time with easily retrievable and reportable regulatory information.

Single source of truth.

Terumo implemented Essenvia to support its busy regulatory affairs teams by centralizing critical global regulatory data. By making Essenvia the single source of truth for regulatory data, Terumo eliminated disparate non-validated systems sprawl that led to inefficient information access and sharing. By centralizing and indexing all regulatory artefacts, Essenvia helped Terumo streamline regulatory workflows, simplify reporting, and established quick access to regulatory information to realize 20% time savings.

Ease of Implementation and Use.

Terumo went live with Essenvia in 90 days thanks to Essenvia’s fit-for-purpose Medtech RIMS and AI-powered automated setup. Early access helped gain broader buy-in and excitement and 5 months later, user satisfaction was high, and all initial desired use cases were successfully implemented.

Flexible architecture to match Terumo’s workflow.

Essenvia’s flexible architecture allowed rapid customization to address known challenges while preserving internal regulatory processes thereby reducing learning curve and accelerating user adoption for the entire regulatory affairs team. High frequency reporting and dashboard in Essenvia were quickly set up saving time and improving visibility across the organization.

What’s next for Terumo

With Essenvia centralizing and indexing regulatory information from over 40,000 artefacts, Terumo unlocked new efficiencies across its organization. From revitalizing registrations management to empowering regulatory affairs teams with digital upskilling for the AI Era. Moving forward, Terumo is integrating AI search, and reporting to accelerate decision making for global regulatory affairs--leveraging Essenvia AI for Regulatory Affairs team and RIMS.