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features
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support

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Description

Flinn serves as an AI-powered platform designed to enhance and simplify the regulatory and quality management tasks within the medical device (MedTech) sector. By allowing manufacturers to incorporate artificial intelligence into intricate and repetitive processes such as post-market surveillance, literature reviews, complaint management, and safety database monitoring, it significantly lessens the manual workload and helps ensure adherence to regulations like the EU Medical Device Regulation (MDR). The platform consolidates information from various sources, utilizes machine learning techniques to identify trends and potential risks, automatically produces reports that meet regulatory standards, and facilitates the swift introduction and operation of high-quality products on a larger scale. Consequently, organizations can realize up to a tenfold increase in process efficiency while also preserving the auditability, transparency, and traceability of their compliance procedures. This innovative approach not only streamlines operations but also empowers companies to focus on innovation and quality in their product offerings.

Description

ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Flinn

Founded

2022

Country

Austria

Website

www.flinn.ai/

Vendor Details

Company Name

DDi

Founded

1997

Country

United States

Website

www.ddismart.com

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