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What is RegDoc eSafe?

Introducing an eReg platform designed specifically for study sites, this solution guarantees swift setup without enforcing strict workflows, featuring a user-friendly interface and capabilities. You can try RegDoc eSafe at no cost today! This platform serves as a secure repository for source documents and comes with tools that enable the transfer, redaction, and assignment of time-limited, role-based access to sensitive data. RegDoc eSafe offers rapid and adaptable configuration options, requires little training for easy navigation, and includes a thorough yet efficient validation procedure. The implementation process is streamlined to quickly ready your clinical study sites for operation, and regulatory binder templates are conveniently accessible within your site for easy retrieval. The platform supports user uploads and has access control settings, supplemented by dedicated training sessions for both administrators and users. MedPoint emphasizes compliance, assisting you in all necessary steps to validate our software successfully. With extensive experience in developing and maintaining validated systems, MedPoint is subject to regular audits by study sponsors, which ensures the highest reliability and quality in our services. Our ongoing commitment to improvement and user satisfaction not only distinguishes us in the industry but also reinforces our dedication to providing exceptional support. Furthermore, we continuously seek feedback from our users to enhance the platform further, ensuring that it meets evolving needs in the field.

What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Media

Media

Integrations Supported

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

Contact MedPoint Digital for pricing details.

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

MedPoint Digital

Company Location

United States

Company Website

www.medpt.com/site-services/

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Document Control

Not specified

Document Management

Compliance Tracking
Document Archiving
Version Control

Categories and Features

Application Lifecycle Management

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

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

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