SMARTSOLVE® EQMS FOR MEDTECH

Accelerate compliance and improve outcomes with AI-enabled QMS for MedTech

Leverage AI-driven insights, automated workflows, and global scalability to streamline operations, reduce risk, and improve patient safety.

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Solutions Safety & Regulatory Compliance Quality Compliance QMS for Life Sciences | SmartSolve | AI- Enabled Compliance - IQVIA SmartSolve eQMS for MedTech

SMARTSOLVE

Improve patient outcomes and company performance

Integrated Quality Processes: Connect over 20 modules in a single platform to cover pre-market, core quality, supplier control, and post-market processes.
AI-Enabled Automation: Leverage AI to improve process efficiency, quality, and company performance.
Analytics & Oversight: Deliver actionable insights with Quality Intelligence powered by Microsoft Power BI for proactive quality management.
Business System Integration: Integrate with a company's existing infrastructure including CRM, ERP, LIMS, MES, and PLM systems via SmartSolve APIs
Data Security & Compliance: Support regulatory requirements with role-based security, audit trails, and electronic signatures; maintain ISO 27001 and ISO 9001 certification.

Strengthen Compliance Across Your Ecosystem

SmartSolve for MedTech empowers Quality Assurance and Regulatory Affairs (QA/RA) teams to manage quality events, mitigate compliance risk, and maintain audit readiness—while aligning with FDA, ISO 13485, and other global regulatory standards.

Core Key MedTech Capabilities for Quality Compliance:

People & Process

Training Management
Ensure team readiness and compliance.
Change Management
Track product and process updates.
CAPA Management
Resolve issues and prevent recurrence.
Deviation & Nonconformance
Identify and correct quality gaps.

Oversight & Intelligence

Audit Management
Simplify internal and external audits.
Quality Event Tracking
Manage incidents with full visibility.
Quality Intelligence
Uncover insights for improvement.
Risk Management
Assess and mitigate compliance risks.

Product & Infrastructure

Asset Management
Control equipment and calibration.
Design Control
Ensure regulatory-compliant product design.
Quality Portal
Centralize documentation and collaboration.

Safeguard Your Brand and Reputation

SmartSolve for MedTech helps QA/RA professionals streamline compliance and meet evolving FDA and EU MDR requirements. Align quality processes, policies, and controls to improve efficiency and audit readiness.

Core Capabilities for MedTech Compliance:

Change Management – Maintain traceability and regulatory control.
Risk Management – Comply with ISO 14971 and mitigate product risks.
Quality Portal – Centralize CAPAs, audits, and training records.
Complaint Management – Simplify FDA and MDR reporting workflows.
Regulatory Connector – Integrate with global regulatory databases.
Post-market Surveillance – Monitor safety and performance post-launch.

Optimize Supply Chain Alignment and performance

SmartSolve for MedTech gives QA/RA teams real-time access to product and quality data—ensuring compliance from design to delivery. Maintain visibility, reduce risk, and meet global regulatory standards with confidence.

Core Key MedTech Capabilities for Supplier Quality Management:

Deviation & Nonconformance Management – Identify and resolve issues early.
Audit Management – Simplify internal and external audits.
Inspection Management – Ensure product quality at every stage.
Quality Portal – Centralize documentation and workflows.
Regulatory Connector – Stay aligned with evolving global regulations.

Confidently Manage Regulated Content Across Global Teams

SmartSolve Digital Content Management helps QA/RA teams manage controlled documents, SOPs, and regulatory assets with confidence. Integrated with Regulatory Intelligence, it supports version control, audit readiness, and seamless collaboration across global teams.

Core Key MedTech Capabilities for Digital Content Management:

Change Management – Maintain traceability across document updates.
Document Management – Control access, versioning, and approvals for regulated content.
Quality Portal – Centralize quality documentation and workflows.

Fact sheet

Boost QA and RA effectiveness throughout the product lifecycle.

Get the latest SmartSolve eQMS for MedTech fact sheet to explore integrated modules, validation tools, and real-time reporting designed to streamline compliance and quality management.

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REQUEST A DEMO

Curious how QA/RA teams use SmartSolve day‑to‑day?

See how to standardize SOPs, improve traceability of quality records, and accelerate market access of high-quality products.

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SmartSolve Frequently Asked Questions

Get quick answers about SmartSolve’s quality management solutions, features, and best practices.

Validation‑ready workflows, audit trails, and integrated design control/UDI/PMS operationalize requirements and keep evidence inspection‑ready.

Yes—start with Complaints/CAPA or Docs/Training, then expand to PMS, Supplier, and Change, aligned to your validation plan.

End‑to‑end SQM—qualification, audits, NC/CAPA, and scorecards—with upstream traceability into change control and PMS.

Open patterns close the loop from engineering changes to reg submissions, training compliance, and production release.

Risk‑based workflows, root‑cause support, and VOE checks drive closure quality and reduce recurrence—backed by dashboards.

IQVIA provides consulting for QMS optimization and recall & field action services for critical events.

Modular and scalable—scope by sites/processes; request a tailored quote via the page RFP form.

SMARTSOLVE® EQMS FOR MEDTECH

Accelerate compliance and improve outcomes with AI-enabled QMS for MedTech

SMARTSOLVE

Improve patient outcomes and company performance

Strengthen Compliance Across Your Ecosystem

People & Process

Oversight & Intelligence

Product & Infrastructure

Safeguard Your Brand and Reputation

Optimize Supply Chain Alignment and performance

Confidently Manage Regulated Content Across Global Teams

Fact sheet

Boost QA and RA effectiveness throughout the product lifecycle.

SmartSolve Frequently Asked Questions

Get quick answers about SmartSolve’s quality management solutions, features, and best practices.

Reimagining Medical Device Innovation Through Integrated Intelligence

The Future of AI in Medical Devices: FDA Guidelines and Global Perspectives

From Compliance to Competitive Edge: How Connected QMS and RIM Empower MedTech QA/RA Teams

The Future of MedTech Compliance: How Dynamic Data Is Transforming Regulatory Processes

Related Solutions

SMARTSOLVE® EQMS FOR MEDTECH

Accelerate compliance and improve outcomes with AI-enabled QMS for MedTech

SMARTSOLVE

Improve patient outcomes and company performance

Strengthen Compliance Across Your Ecosystem

People & Process

Oversight & Intelligence

Product & Infrastructure

Safeguard Your Brand and Reputation

Optimize Supply Chain Alignment and performance

Confidently Manage Regulated Content Across Global Teams

Fact sheet

Boost QA and RA effectiveness throughout the product lifecycle.

SmartSolve Frequently Asked Questions

Get quick answers about SmartSolve’s quality management solutions, features, and best practices.

IQVIA Technologies resources FROM IQVIA EXPERTS

Reimagining Medical Device Innovation Through Integrated Intelligence

The Future of AI in Medical Devices: FDA Guidelines and Global Perspectives

From Compliance to Competitive Edge: How Connected QMS and RIM Empower MedTech QA/RA Teams

The Future of MedTech Compliance: How Dynamic Data Is Transforming Regulatory Processes

Related Solutions