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 tailored for regulated industries. They focus on helping companies navigate complex compliance requirements and improve their quality systems.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated standard, including readiness reviews and gap analysis.
* Corrective and Preventive Action (CAPA): Implementing robust CAPA processes that are data-driven and collaborative, moving beyond project-based approaches.
* Supplier Quality Management (SQM): Offering software solutions for managing supplier performance, compliance, and risk within a structured framework.
* Key Compliance Areas: Support for NERC Compliance, Audit Management, Calibration Management, Change Control, Complaint Handling, Customer Quality, Design Control, Deviation Management, and Document Management.
**Reputation / proof points**
* Focus on regulated industries, including medical devices.
* Emphasis on leveraging technology and data for compliance and quality management.
AssurX provides quality and compliance management software and services tailored for regulated industries. They focus on helping companies navigate complex compliance requirements and improve their quality systems.
**Expertise & scope**
* ISO 13485:2016 Certification Preparedness: Assisting medical device manufacturers in transitioning to the updated standard, including readiness reviews and gap analysis.
* Corrective and Preventive Action (CAPA): Implementing robust CAPA processes that are data-driven and collaborative, moving beyond project-based approaches.
* Supplier Quality Management (SQM): Offering software solutions for managing supplier performance, compliance, and risk within a structured framework.
* Key Compliance Areas: Support for NERC Compliance, Audit Management, Calibration Management, Change Control, Complaint Handling, Customer Quality, Design Control, Deviation Management, and Document Management.
**Reputation / proof points**
* Focus on regulated industries, including medical devices.
* Emphasis on leveraging technology and data for compliance and quality management.
Additional information
AssurX's approach to quality management emphasizes a structured, auditable framework, particularly for supplier quality. Their solutions aim to provide comprehensive visibility into supply chains and enable powerful process control. For CAPA, they advocate for a process-oriented strategy that integrates collaboration, accountability, and data-driven decision-making. This ensures that quality issues are resolved effectively and progress is continuously monitored. Their services support critical compliance areas such as audit management, change control, and document management, helping organizations maintain regulatory adherence.
Key Highlights
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Assists medical device manufacturers with ISO 13485:2016 certification preparedness.
Source
“it is critical for companies to begin transitioning to ISO 13485:2016 certification as soon as possible”
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Promotes a process-oriented approach to CAPA, emphasizing collaboration and data.
Source
“CAPA is a Process, Not a Project: 3 Key Strategies for Success”
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Offers Supplier Quality Management software for controlling supplier processes and supply chain visibility.
Source
“a robust supplier quality management (SQM) software enables powerful supplier process control and comprehensive visibility”
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.
- Companies seeking to improve their CAPA processes.
- Organizations needing to enhance supplier quality management and supply chain visibility.
How engagement typically works
- Technology-driven solutions for quality management.
- Focus on data and collaboration in compliance processes.
- Structured approach to readiness reviews and gap analysis.
Typical deliverables
- ISO 13485:2016 readiness assessments.
- CAPA process implementation and optimization.
- Supplier Quality Management software and framework.
- Support for various compliance management modules (e.g., Document Control, Audit Management).
Good to know
- Best when organizations are ready to invest in software solutions and process improvements for quality and compliance.
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
