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What is RQM+?

RQM+ is a leading global player in the medical technology service sector, focused on helping its clients achieve compliance and market success more quickly. Drawing from extensive knowledge and industry experience, we provide customized solutions that enhance the entire product lifecycle for medical technology companies, guiding them from the initial concept to commercialization and further. Our broad range of services ensures a smooth, end-to-end experience that touches every phase of medical device development. The quality assurance engineers at RQM+ carefully assess material lists, build supplier networks, and aid in managing the design change process. In a similar vein, our design quality engineers focus on critical components such as packaging integrity, sterility assurance, biocompatibility, and necessary device testing procedures. Our regulatory affairs consultants are essential in delivering expert guidance and support with submissions to the FDA, notified bodies, and other regulatory agencies, ensuring that our clients navigate compliance effectively. Furthermore, we utilize our extensive knowledge of current reimbursement protocols and value-based compensation systems to bolster our clients' market positions. By working closely with medical technology companies, RQM+ is devoted to supporting them in achieving their objectives both efficiently and effectively, thereby enhancing their overall market presence. Our mission is to create a lasting impact in the medical technology landscape through our dedicated services and strategic partnerships.

What is Essenvia?

Essenvia significantly boosts corporate value and enhances operational productivity across multiple teams and departments. Functioning as a centralized repository for all regulatory information, it streamlines collaborative document generation and reporting, while also mitigating risks related to technical holds, RTAs, and RFIs. This innovative platform equips regulatory affairs teams with the tools necessary to expedite product launches, thereby preventing potential revenue losses stemming from delays in submissions and overlooked renewals. Offering a detailed perspective of the complete regulatory lifecycle, Essenvia features executive dashboards, key performance indicators, and timely alerts for global registrations, submissions, and modifications. Acting as a Regulatory Information Management (RIM) platform, it optimizes regulatory workflows throughout the product lifecycle, enabling quicker access to global markets and providing substantial competitive advantages. By unifying all regulatory processes into a single platform, businesses can significantly accelerate their entry into the market. Moreover, it contains a centralized archive for all registration documents, which are seamlessly tied to product master data, empowering users to efficiently oversee the product registration lifecycle on a country-specific basis while ensuring compliance and operational excellence. This holistic approach not only enhances efficiency but also fosters better collaboration among teams.

Media

Media

Integrations Supported

Integrations Supported

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

RQM+

Company Location

United States

Company Website

www.rqmplus.com

Company Facts

Organization Name

Essenvia

Company Location

United States

Company Website

essenvia.com

Categories and Features

Categories and Features

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