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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
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Leveraging CAPA for Continuous Improvement
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Organization, Collaboration and Governance for Efficient Changes
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Enhance Safety and Compliance with Smarter Chemical Management
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Partner With Suppliers And Vendors To Improve Quality And Safety
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When Learning Propels Organizational Growth
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Assuring Quality Products and Services
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
The Post-Market Surveillance (PMS) process for medical devices is a critical regulatory requirement designed to ensure ongoing safety and effectiveness of devices after they have been marketed. It involves systematically collecting, analyzing, and interpreting data about a device’s performance and adverse events. Manufacturers must develop a comprehensive PMS plan, which includes gathering end-user feedback, monitoring clinical results, and reviewing scientific literature. Issues identified through PMS may lead to corrective actions, such as updating the product, enhancing training, or even recalling a device. Results from PMS activities must be documented and reported to regulatory authorities to comply with legal obligations and support continuous improvement of the device.
Post-market surveillance (PMS) of medical devices is critical to maintaining patient safety and device efficacy throughout the product lifecycle. The responsibilities involved in PMS include:
An example of post-market surveillance (PMS) involves a manufacturer of cardiac stents. After their stents are released onto the market, the manufacturer actively monitors their performance through various PMS activities. This includes collecting data from hospitals and clinics on the rate of complications such as stent thrombosis or restenosis. They also gather feedback from cardiologists and patients regarding the device's efficacy and any adverse events experienced.
Additionally, the manufacturer regularly reviews scientific literature and participates in clinical registries to compare their stents' performance against others in the market. Based on the outcomes, the manufacturer may update the device's labeling, provide additional training to healthcare providers, or make design modifications. They report these findings and corrective actions to regulatory authorities to ensure compliance and maintain public trust in their product.
Pharmacovigilance and post-market surveillance (PMS) are both crucial processes in monitoring the safety and effectiveness of health products after they have been released to the market, but they focus on different types of products and involve distinct activities:
Both pharmacovigilance and post-market surveillance are integral to regulatory compliance. They are designed to protect public health by ensuring that the benefits of drugs and medical devices continue to outweigh their risks after they reach the market.
ISO 13485 also plays a role in post-marketing surveillance. The standard focuses on ensuring the safety and quality of medical devices throughout their lifecycle.
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