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Intellaquest provides a highly modular “engine”
that aligns & integrates all of your business processes.
Quality Management
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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FDA Issues New Draft Guidance Documents to Strengthen the 510(k) Program for Medical Devices
The FDA has unveiled three new draft guidance documents aimed at refining the 510(k) Program for medical devices.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.
