List of AssurX Manufacturing Quality Management Customers
Morgan Hill, 95037, CA,
United States
Since 2010, our global team of researchers has been studying AssurX Manufacturing Quality Management customers around the world, aggregating massive amounts of data points that form the basis of our forecast assumptions and perhaps the rise and fall of certain vendors and their products on a quarterly basis.
Each quarter our research team identifies companies that have purchased AssurX Manufacturing Quality Management for Quality Management from public (Press Releases, Customer References, Testimonials, Case Studies and Success Stories) and proprietary sources, including the customer size, industry, location, implementation status, partner involvement, LOB Key Stakeholders and related IT decision-makers contact details.
Companies using AssurX Manufacturing Quality Management for Quality Management include: Toray Composite Materials America United States, a United States based Manufacturing organisation with 1000 employees and revenues of $166.0 million, Keystone Dental Group, a United States based Life Sciences organisation with 200 employees and revenues of $35.0 million, Polymedex Discovery Group, a United States based Manufacturing organisation with 196 employees and revenues of $20.0 million and many others.
Contact us if you need a completed and verified list of companies using AssurX Manufacturing Quality Management, including the breakdown by industry (21 Verticals), Geography (Region, Country, State, City), Company Size (Revenue, Employees, Asset) and related IT Decision Makers, Key Stakeholders, business and technology executives responsible for the software purchases.
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| Logo | Customer | Industry | Empl. | Revenue | Country | Vendor | Application | Category | When | SI | Insight |
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Keystone Dental Group | Life Sciences | 200 | $35M | United States | AssurX | AssurX Manufacturing Quality Management | Quality Management | 2022 | n/a |
In 2022, Keystone Dental Group implemented AssurX Manufacturing Quality Management in a Manufacturing Quality Management deployment to automate high-volume complaint handling and regulatory reporting for its US medical device manufacturing operations. The initiative centralized complaint intake workflows and aimed to accelerate case closure and regulatory submission throughput.
The AssurX Manufacturing Quality Management implementation configured complaint intake, case management, adverse event tracking, and electronic regulatory reporting capabilities. Event hooks were created to map implant and assessment data directly to FDA MedWatch/eMDR submissions, automating adverse event creation and routing. Configuration included automated triage rules, standardized investigation records, and audit-ready recordkeeping consistent with medical device quality management practices.
Integration work focused on direct e-submission to FDA MedWatch/eMDR and internal routing to quality and regulatory teams, with event-driven interfaces linking implant lot and assessment metadata to reporting workflows. Operational coverage targeted quality assurance, regulatory affairs, and customer service functions within Keystone Dental Group's United States manufacturing footprint. The system provided case assignment, status tracking, and regulatory packet generation to support cross-functional compliance workflows.
Governance changes established standardized complaint intake procedures, defined escalation paths, and automated regulatory submission governance to reduce manual handoffs. According to the vendor write-up, the automation produced a sustained decline in open complaints, faster time-to-closure, and measurable labor savings exceeding 1,000 hours per year. The deployment emphasized audit trails and controlled records to support FDA reporting obligations.
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Polymedex Discovery Group | Manufacturing | 196 | $20M | United States | AssurX | AssurX Manufacturing Quality Management | Quality Management | 2021 | n/a |
In 2021, Polymedex Discovery Group implemented AssurX Manufacturing Quality Management Apps Category . The initial deployment targeted the companys Putnam, CT cGMP manufacturing site and focused on standardizing document control and training to meet ISO 13485 and FDA cGMP 21 CFR parts 210 and 211 requirements.
Foster Delivery Science implemented AssurX Document Management and AssurX Training Management modules as part of the AssurX Manufacturing Quality Management rollout, configuring document import and indexing workflows and mapping training records to controlled documents. The implementation established centralized document version control, structured approval routing, and training assignment and attestation processes to enforce procedural compliance.
The deployment was US focused and emphasized improving document import and indexing to drive user adoption at the manufacturing site. Operational coverage was limited to the Putnam production footprint during the initial phase, with planning articulated to expand AssurX Manufacturing Quality Management into calibrations, preventive maintenance, change control, supplier management and CAPA according to the vendor announcement.
Governance included standardized document control processes and training governance to align site procedures with ISO 13485 and FDA cGMP expectations, and the project emphasized operational standardization and user adoption rather than system consolidation. AssurX Manufacturing Quality Management now serves document control and training functions for Polymedex Discovery Group at the Putnam cGMP site.
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Toray Composite Materials America United States | Manufacturing | 1000 | $166M | United States | AssurX | AssurX Manufacturing Quality Management | Quality Management | 2023 | n/a |
In 2023, Toray Composite Materials America implemented AssurX Manufacturing Quality Management to digitize nonconformance and quality incident workflows. The deployment targeted Manufacturing Quality Management across its US manufacturing sites, with a focus on deviations, complaints, change management and audit management.
Toray configured over 60 action request forms inside AssurX Manufacturing Quality Management to automate intake, root cause analysis and resolution and to reduce labor on manual processes. The implementation centralized case intake, enforced structured root cause workflows and tracked corrective actions to improve accountability and accelerate problem resolution, outcomes reported by the vendor.
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