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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
RegPass™ serves as a compliance co-pilot designed to amplify your team's effectiveness tenfold. It seamlessly integrates every phase of the regulatory change lifecycle, from horizon scanning to assurance: Horizon Scanning → Rules Inventory → Policies & Controls → Regulatory Policy Advisor.
With extensive global coverage and smart Business Profiles that tailor alerts to what matters most, you can remain proactive. Our enhanced Rules Inventory streamlines overlapping obligations into clear, canonical forms for better traceability and understanding.
At the core of RegPass is AI, which extracts, ranks, and aligns obligations to your existing policies and controls, providing thorough justification for each recommendation. Every recommendation is well-documented, auditable, and primed for your approval.
Developed by the specialists at Braithwate, RegPass encapsulates years of regulatory change knowledge into a dynamic knowledge graph. With its open, extensible, and inherently transparent design, RegPass ensures complete traceability, enabling teams to operate more efficiently, minimize risk, and bolster compliance. By leveraging such a powerful tool, organizations can navigate the complexities of regulatory landscapes with confidence and clarity.
API Access
Has API
API Access
Has API
Screenshots View All
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Integrations
Archer
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
RegPass
Founded
2019
Country
United Kingdom
Website
www.regpass.ai