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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

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
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

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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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

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
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

Document Control Features

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Integrations

Jira
Microsoft 365
Salesforce

Integrations

Jira
Microsoft 365
Salesforce
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