RegDoc eSafe

RegDoc eSafe

MedPoint Digital
+
+

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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

An eReg platform built with the study site in mind. Fast implementation, no forced workflow, intuitive design and function. Try RegDoc eSafe free today! A secure lock-box for source documents, with tools that make it easy to transfer, redact and assign role-based, time-limited remote access to these sensitive documents. RegDoc eSafe is designed for fast, flexible configuration, intuitive use with minimal training, and a thorough but streamlined validation process. Streamlined implementation process to get your clinical study sites up and running quickly. Regulatory binder templates pre-loaded into your site for easy access. User upload and access control configuration. Admin and user training sessions. MedPoint is committed to compliance and walks you through the necessary steps to validate our software. MedPoint is regularly audited by study sponsors and has long experience developing and supporting validated systems.

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

Researchers and analytic experts searching for a solution to improve and manage their operations

Support

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

Support

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

Contact MedPoint Digital for pricing details.
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:

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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 Supported
Live Online Supported
In Person Supported

Training

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

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

MedPoint Digital
United States
www.medpt.com/site-services/

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Categories

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

Document Control Features

Archiving & Retention Not Supported
Automated Routing Not Supported
Change Management Not Supported
Compliance Management Not Supported
Electronic Signature Not Supported
Escalation Management Not Supported
Periodic Review Not Supported
Version Control Not Supported

Document Management Features

Access Controls Not Supported
Archiving & Retention Not Supported
Collaboration Tools Not Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Not Supported
Document Capture Not Supported
Document Conversion Not Supported
Document Delivery Not Supported
Document Indexing Not Supported
Document Retention Not Supported
Electronic Signature Not Supported
Email Management Not Supported
File Recovery Not Supported
File Type Conversion Not Supported
Forms Management Not Supported
Full Text Search Not Supported
Offline Access Not Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Integrations

Jira Supported
Microsoft 365 Supported
Salesforce Supported

Integrations

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