+
+

Related Products

  • Predict360
    18 Ratings
    Visit Website
  • Haast
    1 Rating
    Visit Website
  • Hyperproof
    346 Ratings
    Visit Website
  • Qualio
    900 Ratings
    Visit Website
  • RegDesk
    19 Ratings
    Visit Website
  • Interfacing Integrated Management System (IMS)
    66 Ratings
    Visit Website
  • SDS Manager
    4 Ratings
    Visit Website
  • Captain Compliance
    246 Ratings
    Visit Website
  • Jama Connect
    386 Ratings
    Visit Website
  • AestheticsPro
    721 Ratings
    Visit Website

About

Flinn is an AI-driven platform built to automate and streamline regulatory and quality-management processes within the medical-device (MedTech) industry. It enables manufacturers to integrate AI into repetitive and complex workflows such as post-market surveillance, literature evaluation, complaint-handling, and safety-database monitoring, reducing manual effort and ensuring compliance with standards like the EU Medical Device Regulation (MDR). It aggregates data across sources, applies machine-learning algorithms to detect patterns and risks, generates regulatory-compliant reports automatically, and supports rapid launch and operation of high-quality products at scale. As a result, organizations can achieve up to a tenfold acceleration in process efficiency while maintaining auditability, transparency, and traceability of their compliance workflows.

About

Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

MedTech companies’ quality, regulatory and compliance teams seeking a tool to automate and scale regulatory workflows, achieve faster product launch and ensure full compliance with global medical-device regulations

Audience

Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Flinn
Founded: 2022
Austria
www.flinn.ai/

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Alternatives

Alternatives

Modern Requirements4DevOps

Modern Requirements4DevOps

Modern Requirements
ViSU

ViSU

DDi
aligned elements

aligned elements

Aligned AG
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Categories

Application Lifecycle Management Features

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management Features

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Integrations

Jira
Microsoft 365
Salesforce

Integrations

Jira
Microsoft 365
Salesforce
Claim Flinn and update features and information
Claim Flinn and update features and information
Claim Orcanos and update features and information
Claim Orcanos and update features and information