Clearlane Risk Register

Clearlane Risk Register

Clearlane Apps
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About

Clearlane Risk Register is a risk-management app for Jira Cloud that lets teams record, assess, treat, review and retain evidence for project risks within Jira. Risks can be scored on a 5 × 5 map, with assessments before and after treatment, and templates support ISO 14971, FMEA, ISO 27001, NIS2, CRA and DORA workflows. Treatment decisions and follow-up actions are tracked as Jira work items with owners, statuses and due dates. Review intervals, reminders, signed reviews and a history help teams maintain an auditable record, while PDF evidence files collect assessment and treatment information. The app is built for quality, product-safety, risk and security teams using Jira Cloud, including medical-device organizations and teams working with security and regulatory risk frameworks.

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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Supported
Chromebook Not Supported

Audience

Quality, risk and security teams at medical device manufacturers, NIS2 entities and ISO 27001 organizations using Jira Cloud.

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 Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$0
Free for up to 10 users.
Free Version Supported
Free Trial Supported

Pricing

No information available.
Free Version Supported
Free Trial Supported

Reviews/Ratings

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

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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 Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Clearlane Apps
Founded: 2026
France
clearlaneapps.com/risk-register/

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

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Categories

Risk Management Supported

Categories

Application Lifecycle Management Features

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

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Integrations

Jira Supported
Microsoft 365 Not Supported
Salesforce Not Supported

Integrations

Jira Supported
Microsoft 365 Supported
Salesforce Supported
Claim Clearlane Risk Register and update features and information
Claim Clearlane Risk Register and update features and information
Claim Orcanos and update features and information
Claim Orcanos and update features and information