Leverage intelligent automation, real-time analytics, and global scalability to minimize risk and accelerate approvals. Transform quality processes for MedTech and Pharma to improve patient outcomes worldwide.
AI-Enabled Quality and Regulatory Management:
Real-time visibility and control over quality, regulatory, and supplier processes with modular, scalable solutions.
Comprehensive Compliance Tools:
Includes Change Management, Document Management, Training Management, Registration & Submission Management, Health Authority Interaction, Publishing, Quality Event Management, Deviation & Nonconformance Management, Inspection Management.
Smart Platform Technology:
Built on Microsoft Azure AI, with advanced analytics, technical and regulatory frameworks, and SmartStudio configuration for seamless integration and scalability.
Industry Expertise:
Leverage deep domain knowledge and technology that adapts to your business needs.
Business Impact:
Drive product quality, patient safety, and commercial performance with a unified eQMS platform.
We evaluated multiple systems to ensure we chose the best fit for our needs. SmartSolve stood out due to its comprehensive features, ease of use, and robust support for compliance and reporting.
Hannah Seevaratnam
Vice President, Quality and Regulatory, Robling Medical
SmartSolve unifies enterprise Quality Management (eQMS) and Regulatory Information Management (RIM) on a single, secure cloud platform, streamlining compliance and accelerating product delivery.
Powered by IQVIA Regulatory Intelligence and IQVIA Vigilance Detect, SmartSolve delivers AI-driven analytics, real-time insights, and closed-loop compliance.
Built on Microsoft Azure and backed by IQVIA’s global expertise, SmartSolve helps you meet FDA, EU MDR, and ISO 13485 requirements, scale globally, and bring safer, higher-quality products to market faster.
Request a SmartSolve eQMS demo for Pharma & MedTech.
Million users globally
Million complaints managed
Million certifications conducted
IQVIA’s SmartSolve® eQMS has been honored with a Bronze Stevie® Award for Healthcare Technology Solution, recognizing its innovative role in transforming quality management for MedTech and life sciences. Read more.
F&S awards IQVIA with Best Practices Customer Value Leadership Award in the global artificial intelligence regulatory and quality solutions space for the healthcare industry. Read more.
IQVIA’s SmartSolve eQMS is recognized for the “Best Use of Artificial Intelligence in Healthcare. Read more.
SmartSolve is recognized with Frost & Sullivan’s 2023 North American Enabling Technology Leadership Award in the QMS market for life sciences industry. Read more.
Hear our experts discuss ways in which risks associated with AI can be reduced and regulatory systems potentially be improved.
Learn what role technology (including AI) can play in supporting quality and regulatory teams to enhance their daily performance.
Discover how AI-powered eQMS solutions are transforming MedTech and Pharma by enhancing compliance, product quality, and patient safety.
Uncover how Generative AI could be your solution to tackle the mounting challenges in safety, regulatory and quality management and achieve the next level of maturity for AI in your organization.
AI advancements in the life sciences industry have led to rapid progress and emerging challenges, prompting regulatory bodies to update regulations to address new risks. Early integration of quality assurance and regulatory affairs (QARA) professionals in medical device development is crucial for navigating evolving global regulations and cybersecurity threats.
Discover how the right eQMS empowers businesses to take a proactive approach to quality and compliance processes.
The award-winning SmartSolve eQMS for MedTech and Pharmaceutical companies enhances quality and improves regulatory compliance, enabling organizations to deliver life-changing therapies to patients faster.
Small and emerging biopharma can also be at the forefront of tech innovation by automating their quality compliance management with IQVIA SmartSolve Fundamentals.
.svg){kind=icon}
