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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.

About

SoftTech Health offers the most comprehensive suite of quality management software tools available in healthcare today. And since they integrate seamlessly, you’ll be able to streamline all your quality management tasks within one easy-to-use software package. Our Accreditation Manager helps you manage any upcoming inspections with tools to help you compare and copy over existing work from previous inspections. Automatically track proof of compliance and ensure nothing falls through the cracks. With every inspection, you want to: make sure that none of the requirements fall through the cracks; cut time to coordinate, track, and report on the audit; and streamline the time-consuming process of gathering your supporting evidence. The Accreditation Manager automates all these processes, improving both compliance and the bottom line at the same time.

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

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

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

Audience

Healthcare organizations looking for an inspection management software with tools for previous data and compliance track

Support

Phone Support 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

No information available.
Free Version Supported
Free Trial Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

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 Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

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

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

SoftTech Health
Founded: 2003
United States
softtechhealth.com/products/

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Categories

Categories

CAPA Supported
Quality Management Supported

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

Accreditation Management Features

Collaboration Supported
Compliance Management Not Supported
Document Management Supported
Higher Education Not Supported
Requirements Management Not Supported
Reviewer Portal Not Supported
Self Assessment Not Supported
User Access Permissions Not Supported
Workflow Management Not Supported

Integrations

Jira Supported
Microsoft 365 Supported
Salesforce Supported

Integrations

Jira Not Supported
Microsoft 365 Not Supported
Salesforce Not Supported
Claim Orcanos and update features and information
Claim Orcanos and update features and information
Claim SoftTech Health and update features and information
Claim SoftTech Health and update features and information