AssurX
TSI
TSI provides precision measurement solutions, software, and services for industries like environmental monitoring and health. They offer expert instrument service, repair, and calibration.
TSI is dedicated to creating a better world by protecting people, products, and the environment, while optimizing research and industrial processes. With over 60 years of experience, TSI Service delivers excellent and prompt instrument service, repair, and calibration through their expert technicians. They cater to a wide range of industries including Electronics Manufacturing, Emergency Response & Law Enforcement, HVAC and TAB Consultants, Indoor Environments, Industrial Manufacturing, Life Sciences, Occupational Health and Safety, Outdoor Environments, Power Generation and Mining, and Research and Development. TSI's commitment is to hire passionate individuals who take initiative to exceed customer expectations, contributing to the development of products and services that safeguard people and the environment.
About
**Who they are**
AssurX provides quality and compliance management software and services, with a focus on helping regulated companies navigate complex compliance landscapes. They offer solutions designed to manage critical quality processes and ensure adherence to industry standards.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated ISO 13485 standard, incorporating risk-based methodologies.
* Corrective and Preventive Action (CAPA): Implementing CAPA as a continuous process, emphasizing collaboration, accountability, and data-driven decision-making.
* Supplier Quality Management (SQM): Enabling control over supplier quality, performance, and compliance through structured software solutions, addressing supply chain risks and inefficiencies.
* Document Management: Facilitating the management of critical quality documents.
* Audit Management: Supporting audit processes within a quality management system.
* Complaint Handling: Managing customer complaints as part of a comprehensive quality system.
**Reputation / proof points**
* Focus on regulated industries, including medical devices.
AssurX provides quality and compliance management software and services, with a focus on helping regulated companies navigate complex compliance landscapes. They offer solutions designed to manage critical quality processes and ensure adherence to industry standards.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated ISO 13485 standard, incorporating risk-based methodologies.
* Corrective and Preventive Action (CAPA): Implementing CAPA as a continuous process, emphasizing collaboration, accountability, and data-driven decision-making.
* Supplier Quality Management (SQM): Enabling control over supplier quality, performance, and compliance through structured software solutions, addressing supply chain risks and inefficiencies.
* Document Management: Facilitating the management of critical quality documents.
* Audit Management: Supporting audit processes within a quality management system.
* Complaint Handling: Managing customer complaints as part of a comprehensive quality system.
**Reputation / proof points**
* Focus on regulated industries, including medical devices.
Additional information
AssurX's software solutions are designed to streamline critical quality processes, making them particularly relevant for companies facing regulatory scrutiny. Their CAPA module, for instance, is presented not as a one-off project but as an ongoing process requiring stakeholder involvement and data analysis for effective issue resolution. For supplier quality, their approach emphasizes a structured, auditable framework to gain visibility and control over the supply chain, which is crucial for mitigating risks associated with outsourcing and manufacturing complexities. Buyers should consider how these integrated modules can support their overall QMSR transition and inspection readiness by standardizing and documenting key quality activities.
Key Highlights
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Assists with ISO 13485:2016 certification preparedness, emphasizing a risk-based methodology.
Source
“Accordingly, it is critical for companies to begin transitioning to ISO 13485:2016 certification as soon as possible”
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Provides software solutions for managing Corrective & Preventive Actions (CAPA) as a process, not a project.
Source
“CAPA is a Process, Not a Project: 3 Key Strategies for Success”
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Offers Supplier Quality Management (SQM) software to control supplier performance and compliance within a structured framework.
Source
“a robust supplier quality management (SQM) software enables powerful supplier process control and comprehensive visibility into the state of your supply chain.”
Certifications & Trust Signals
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Offers solutions for Audit Management, Calibration Management, Change Control, Complaint Handling, and Document Management.
Source
“Audit Management Calibration Management Change Control Complaint HandlingeMDREU MDR Corrective & Preventive Action Customer Quality Design Control Deviation Management Document Management EHS Incident Management”
Buyer Snapshot
Best for
- Medical device manufacturers preparing for ISO 13485:2016 transition
- Companies seeking to improve CAPA process efficiency
- Organizations needing to enhance supplier quality management
How engagement typically works
- Software-driven solutions
- Focus on process integration
- Data-driven quality management
Typical deliverables
- Quality Management Software Modules (e.g., CAPA, SQM, Document Control)
- Guidance on ISO 13485:2016 transition
- Tools for managing supplier audits and performance
Good to know
- Best when integrated into a broader quality management system strategy.
HQ:
Shoreview, US
Languages:
English
Timezones:
PST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals
Onboarding time:
10–21 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, Internal Audit Program Upgrade
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, SOP/Documentation Remediation, Internal Audit Program Upgrade
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
ISO 13485 lead auditor capability
