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INTELLAQUEST PROVIDES IMPACT THAT MAKES A DIFFERENCE

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Intellaquest provides a highly modular “engine”
that aligns & integrates all of your business processes.

Quality Management
System

EHS
Management System

Supplier
Management System

Operations & Plant Management System

Engineering
Management System

Audit
Management System

Asset
Management System

Training
Management System

Project
Management System

Innovation/
New Product Dev
Management System

Risk & Compliance
Management System

Contractor
Management System

Warranty
Management System

Production Parts
Approval Process Management System

GRC
Management System

Latest Articles

Transitioning 510(k) Submissions to eSTAR – Are You Ready?

The FDA's new electronic Submission Template And Resource (eSTAR) is revolutionizing the 510(k) submission process for medical devices. This interactive PDF form not only streamlines the submission process but also integrates multiple resources, ensuring a comprehensive and high-quality submission. With the mandatory transition to eSTAR submissions starting October 1, 2023, it's crucial for medical device manufacturers to familiarize themselves with this tool.

FDA Issues New Draft Guidance Documents to Strengthen the 510(k) Program for Medical Devices

The FDA has unveiled three new draft guidance documents aimed at refining the 510(k) Program for medical devices. These documents, part of the FDA's ongoing efforts to enhance the clarity and consistency of the 510(k) Program, emphasize the importance of selecting appropriate predicate devices, the use of clinical data, and setting evidentiary expectations for implant devices. As the regulatory landscape evolves, the significance of a robust Quality Management System (QMS) becomes even more paramount. A well-implemented QMS not only ensures compliance but also fosters a culture of continuous improvement and quality.

VoC: To Understand How to Capture Customer Perceptions, You Need to First Understand Why They Matter

Discover the synergy between customer perceptions, Voice of the Customer (VoC), and Quality Function Deployment (QFD) as underpinned by the timeless PDCA cycle. Dive deep into how ISO 9001:2015 places the customer at the heart of quality management and how modern businesses can harness these principles for continual improvement, agility, and sustained success. From understanding the nuances of capturing VoC to translating it effectively into product features via QFD, this article showcases the importance of an iterative approach to stay attuned to evolving customer expectations.

A comprehensive set of Applications that are integrated and modular

Learn how each application can help you ‘work intelligently’

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