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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

RQM+ stands as a prominent global provider of medical technology services, dedicated to accelerating compliance and ensuring market success for its clients. With a wealth of expertise and deep industry insight, we offer tailored solutions that streamline the entire product lifecycle for medical technology firms, guiding them from initial concept through to commercialization and beyond. Our comprehensive suite of services facilitates seamless end-to-end solutions that encompass every stage of the medical device development process. The quality assurance engineers at RQM+ meticulously evaluate material lists, establish supplier networks, and assist in navigating the design change process. Likewise, our design quality engineers are instrumental in overseeing crucial aspects such as packaging, sterility, biocompatibility, and required device testing. Our regulatory affairs consultants play a vital role by providing expert guidance and assistance with submissions to the FDA, notified bodies, and other regulatory agencies. Additionally, we leverage our significant experience with current reimbursement requirements and value-based compensation frameworks to enhance our clients' market positioning. Ultimately, RQM+ is committed to empowering medical technology companies to achieve their goals efficiently and effectively.

Description

TraxQM is a risk-oriented Quality Management System (QMS) aimed at assisting organizations in navigating regulatory compliance, optimizing quality workflows, and boosting operational effectiveness via a unified, AI-driven platform. This system empowers businesses to adopt a proactive stance toward compliance by digitizing their procedures and implementing structured approaches that comply with global standards like ISO and GxP. Featuring essential modules for managing documents, conducting risk assessments, overseeing Corrective and Preventive Actions (CAPA), implementing change control, executing audits, and facilitating training, TraxQM allows teams to handle the entire spectrum of quality operations within a single system. The platform ensures data integrity through features like automated version control, audit trails, and compliant electronic signatures, which guarantee traceability and adherence to regulatory mandates. Furthermore, TraxQM utilizes artificial intelligence to bolster decision-making by evaluating risks, proposing specific control measures, and recommending pertinent Key Performance Indicators (KPIs) aligned with the organization’s goals, thereby enhancing overall quality management capabilities. Ultimately, this comprehensive QMS not only streamlines processes but also empowers teams to foster a culture of continuous improvement in their quality practices.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Docusign
Microsoft 365

Integrations

Docusign
Microsoft 365

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$403.97 per month
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

RQM+

Country

United States

Website

www.rqmplus.com

Vendor Details

Company Name

TraxQM

Country

United States

Website

www.traxqm.com

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