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About

RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models.

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.

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

Medical technology companies in search of a solution to manage their compliance and regulation processes

Audience

Medical Devices, Pharmaceuticals, and IVD companies

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

Contact us to learn more.
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 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

RQM+
United States
www.rqmplus.com

Company Information

RegDesk
Founded: 2014
United States
www.regdesk.co

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Categories

Categories

Integrations

Active Directory
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Boomi
Dynamics 365 Customer Service
Jira
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Okta
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Oracle ADF Faces
PTC Windchill
Qualio
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SnapLogic

Integrations

Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
PTC Windchill
Qualio
Resource Management by Smartsheet
SnapLogic
Claim RQM+ and update features and information
Claim RQM+ and update features and information