Regulatory Information Management Software

ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed speciﬁcally for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control.

ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction.

The
ViSU
Advantage

100% Cloud-Based

Access at any time, from anywhere using secure private cloud. ViSU is a single source for information and implementation enabling you to focus on execution and compliance

Scalable

Whether you’re a small-midsized business focusing to become a global company or already have a global presence, we are ready. Medical device companies can choose to implement the entire RIM System or few solution modules. ViSU offers modular approach ensuring you have “fit-for-purpose” platform

Simplified Pricing

ViSU offers modular and simple pricing, so there are no surprises. All Cloud and you can add/drop modules anytime.

Integrations

Integrate your existing Quality Management System (QMS) or ERP/PLM with ViSU with pre-built connectors reducing implementation time and costs.

Execute your company strategy and accelerate global product registrations, submissions and tracking

Move Fast

Accelerate time to market by better business process integration to plan, execute, and track all global regulatory activities in a single, integrated RIM application, with continuous access to regulatory documents and full support for global regulatory submission requirements to speed-up health authority submission timelines. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.

Reduce Regulatory Risk to Future-Proof Compliance

Reduce risk and stay compliant with the latest regulatory requirements with a built-in Reg Intel that keeps you up-to-date in real-time. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.

Simplify the Regulatory Lifecycle

Manage the entire regulatory lifecycle in a single platform with intuitive, ease to use user interface, for faster adoption and better ROI. Streamline planning and tracking of interactions, commitments and obligations, as well as document and dossier management, publishing, reporting, and data standards compliance with our alert management system. Integrated reports and charts support management’s overview of critical renewal dates, current ongoing activities, and finalized tasks completed in the last few months.

Reduce Manual Efforts with Smart Forms & Automation

Add efficiency without losing control by automating manual workflows including intelligent task assignment, submission planning, and performance tracking and increase connectivity for improved efficiency, decreased costs, better coordination and cross-enterprise visibility. Our pre-configured templates help expedite regulatory submission and dossier planning. Automatic notifications help you to inform the assigned users about new tasks or send reminders before due date

Modules

Reg Intel (Global requirement live DB)

Country-specific regulatory updates (120+ country specific regulatory requirements) that link to your products for effective impact analysis and change control.

Product Master

Central Repository of detailed product information to serve as single system of truth that integrates with 3rd party systems (PLM, ERP).

Registrations & Tracking

Create, track and manage global registrations and regulatory applications that can be tracked by product, country, SKU, franchise and more.

Submissions

End-to-End submission life-cycle management, from planning to author to publishing to archival.

Commitments/Obligations

Creates auto-commitments based on built-in country specific requirements and alerts you to minimize missing events.

Correspondence

Automate all entries (Create and track HA Correspondence) with built-in email extractor that pulls different emails and links to your products.

UDI

Automate (prepare, validate, submit and track) medical device UDI Submissions and integrate to product registration life-cycle.

Standards

Monitor and manage Medical Device Standards and automate alerts or updates on subscribed standards by linking to products for proactive risk management.

eIFU/Labeling

Web-based portal linked to products with internal and public web pages with several languages included. Access control, remote print and more to maintain full compliance