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 designed to help regulated companies navigate complex compliance landscapes. They focus on enabling organizations to manage quality processes effectively.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated ISO 13485 standard, including readiness reviews and gap analysis.
* Corrective and Preventive Actions (CAPA): Offering strategies and solutions for managing CAPA as a continuous process, emphasizing collaboration, accountability, and data-driven decisions.
* Supplier Quality Management (SQM): Providing software and frameworks for managing supplier quality, performance, and compliance within a structured, auditable system to control supply chains and mitigate risk.
* Quality Management System Components: Supporting critical QMS areas such as Audit Management, Calibration Management, Change Control, Complaint Handling, Design Control, Deviation Management, and Document Management.
**Reputation / proof points**
* Focus on regulated industries requiring robust quality systems.
AssurX provides quality and compliance management software and services designed to help regulated companies navigate complex compliance landscapes. They focus on enabling organizations to manage quality processes effectively.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated ISO 13485 standard, including readiness reviews and gap analysis.
* Corrective and Preventive Actions (CAPA): Offering strategies and solutions for managing CAPA as a continuous process, emphasizing collaboration, accountability, and data-driven decisions.
* Supplier Quality Management (SQM): Providing software and frameworks for managing supplier quality, performance, and compliance within a structured, auditable system to control supply chains and mitigate risk.
* Quality Management System Components: Supporting critical QMS areas such as Audit Management, Calibration Management, Change Control, Complaint Handling, Design Control, Deviation Management, and Document Management.
**Reputation / proof points**
* Focus on regulated industries requiring robust quality systems.
Additional information
AssurX's approach to quality management emphasizes leveraging technology to streamline complex processes. For ISO 13485 preparedness, they highlight the importance of a corporate readiness review to identify gaps in the quality management system. Their CAPA solutions focus on integrating collaboration and accountability, linking decisions to data, and utilizing technology to manage the process effectively. For supplier quality, their software aims to provide comprehensive visibility and control over the supply chain, addressing challenges related to outsourcing and potential disruptions. Buyers should consider how these integrated software solutions can support their specific regulatory and operational needs.
Key Highlights
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Assists medical device manufacturers with ISO 13485:2016 certification preparedness.
Source
“Accordingly, it is critical for companies to begin transitioning to ISO 13485:2016 certification as soon as possible, if not in the process already.”
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Provides strategies for managing Corrective and Preventive Actions (CAPA) as a process, not a project.
Source
“The challenge of the quality manager is to convince stakeholders of their responsibilities and accountability in the CAPA process, provide them with solutions that help them succeed...”
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Offers Supplier Quality Management (SQM) software for structured, auditable control of supply chains.
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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Provides software and services for quality and compliance management in regulated industries.
Source
“Quality & Compliance Management Software”
Buyer Snapshot
Best for
- Medical device manufacturers preparing for ISO 13485:2016 certification
- Companies seeking to improve their CAPA process management
- Organizations needing to enhance supplier quality oversight
How engagement typically works
- Technology-driven solutions
- Process-oriented approach
Typical deliverables
- Quality management software
- Compliance readiness assessments
- CAPA process improvement strategies
- Supplier quality management frameworks
Good to know
- Best when organizations are looking for software-based solutions to manage quality and compliance processes.
HQ:
Shoreview, US
Languages:
English
Timezones:
PST
Claim 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, SOP / Documentation Remediation, CAPA & Nonconformance Remediation, Internal Audit Program Upgrade, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start:
flexible
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly
eqms_software_comparison
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
ISO 13485 lead auditor capability
