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.
Request a Live Demo
Solutions Safety & Regulatory Compliance Quality Compliance SmartSolve® eQMS for Lifesciences SmartSolve eQMS for MedTech
background accent graphic

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.
download fact sheet
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.
Request a QA/RA‑focused demo

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.

IQVIA Technologies resources FROM IQVIA EXPERTS

Fact Sheet
SmartSolve® Automated Validation and Extended Validation Services
White Paper
From Paper to Platform: The AI-Driven Evolution of Quality Management Systems
Article
Reimagining Medical Device Innovation Through Integrated Intelligence
Blog
The Future of AI in Medical Devices: FDA Guidelines and Global Perspectives
By: Mike King
Article
From Compliance to Competitive Edge: How Connected QMS and RIM Empower MedTech QA/RA Teams
Blog
The Future of MedTech Compliance: How Dynamic Data Is Transforming Regulatory Processes
By: Anusha Gangadhara
Prev
Next

Related Solutions

SmartSolve® eQMS for Pharma

Centralize quality processes for complex portfolios or shared QA teams, ensuring consistent compliance and audit-ready documentation.

SmartSolve® RIM

Connect change control directly to submission and registration management, streamlining regulatory workflows and improving traceability.

Contact Us