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About

RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.

About

Temis, the tool with which you can manage your professional and business affairs in a simple, efficient and intuitive way. Manage your affairs to deliver results in a timely manner, always as a team and in an easy, safe and efficient way. TIMELY Make decisions effectively with accurate and objective information. COLLABORATIVE Work as a team and facilitate real-time communication between your collaborators. SUPPORT Customer service and access to a knowledge base. AVAILABLE Ensures access to information from anywhere, in real time and safely. PRODUCTIVE Increase the performance of your work team as a result of better management of your affairs and priorities. INTUITIVE Easy to use, with a simple and friendly interface that simplifies your daily tasks.

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 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

Medical Devices, Pharmaceuticals, and IVD companies

Audience

teams looking for a platform to manage professional and business affairs in a simple, efficient and intuitive way

Support

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

Support

Phone Support Not 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

No images available

Pricing

Contact us to learn more.
Free Version Not Supported
Free Trial Not Supported

Pricing

$30 / mo / annual
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

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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Pros from Real Users

Pros

  • Comprehensive, user-friendly tool that consolidates all regulatory affairs processes in one place. Excellent support provided by real experts that add value to our business.
  • The User Interface is very elegant and engaging to use. The Global view of Alerts, Standards and Regulations is appealing and consolidated and is a useful tool for regulatory intelligence.
  • RegDesk is easy to deploy, entirely web-based with streamlined user access management. Its UI is intuitive which makes training users simple. Its modular structure reduces complexity for folks working on specific topics, which may not relate to the work of another colleague -- for example, Regulatory Intelligence and market access requirements appear in one module, while tracking submissions is in another. Additionally, tracking postmarket "where-can-I-ship?" elements is simple and straightforward with a SKU and country-code database.
  • Compliance is critical in the medical device world to ensure safety of users and patients. Compliance tracking allows companies to establish and maintain a validated state of control, while looking at efficient ways to stay ahead of changing regulations. Documentation Management allows organizations to prepare for future growth by reviewing content from multiple dossiers and leverage similarities of content increase speed to submission. In many situations’ documents are updated as products progress through lifecycle and by managing documentation change electronically increases efficiency. Utilizing reporting and statistics during business planning allows Regulatory Affair heads to show organizations the return on investment for regulatory departments. Reporting on the number of requests, submissions, approved/cleared submissions and timelines allows key performance indicators to be develop. Being able to report on the number of international requests allowed for the organization to enhance their approach on global expansion. Easy to implement and utilize, customization and collaboration with RegDesk team, tracking to allow for reporting to organizations allowing for visibility of global changes/updates.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

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

Company Information

RegDesk
Founded: 2014
United States
www.regdesk.co

Company Information

Temis
Mexico
temis-apps.com

Alternatives

Alternatives

Rimsys

Rimsys

Rimsys Regulatory Management Software
Redica

Redica

Redica Systems
MedAffairs AI

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)
Freya

Freya

Freyr Solutions
RIMTrack

RIMTrack

WinWire Technologies
ACMA Engage

ACMA Engage

Accreditation Council for Medical Affairs (ACMA)

Categories

Categories

Task Management Supported

Task Management Features

Collaboration Supported
Create Subtasks Supported
Gamification Not Supported
Gantt Charts Not Supported
Mobile Access Supported
Percent-Complete Tracking Not Supported
Progress Tracking Not Supported
Recurring Tasks Not Supported
Reporting/Analytics Supported
Spreadsheet View Supported
Task Board View Supported
Task Planning Not Supported
Task Scheduling Supported
Task Tracking Supported
Time Tracking Supported
To-Do List View Not Supported

Integrations

Active Directory Supported
Arena Supported
Asana Supported
Boomi Supported
Dynamics 365 Customer Service Supported
Jira Supported
MuleSoft Anypoint Platform Supported
Okta Supported
OpenText AI Operations Management Supported
Oracle ADF Faces Supported
PTC Windchill Supported
Qualio Supported
Resource Management by Smartsheet Supported
SnapLogic Supported

Integrations

Active Directory Not Supported
Arena Not Supported
Asana Not Supported
Boomi Not Supported
Dynamics 365 Customer Service Not Supported
Jira Not Supported
MuleSoft Anypoint Platform Not Supported
Okta Not Supported
OpenText AI Operations Management Not Supported
Oracle ADF Faces Not Supported
PTC Windchill Not Supported
Qualio Not Supported
Resource Management by Smartsheet Not Supported
SnapLogic Not Supported
Claim Temis and update features and information
Claim Temis and update features and information