Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
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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
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
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
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
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
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
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
Medical devices come in various forms and for various purposes. They could range from pacemakers, to insulin pump, prosthetic limb, catheters, and so on, and impact the health and lives of people using them. This makes them critical for the survival of the patients and their quality, performance, and safety are of paramount importance.
To ensure this, regulatory bodies lay stress on the quality management processes at every stage of the product development, manufacturing, product, and service delivery. Ensuring the compliance of products to standards, their quality, performance, and safety is quality assurance. Medical equipment quality assurance focuses on the quality of the processes associated with the product right from design to obsolescence, proactively managing quality and preventing risk factors from turning into hazards and events.
Quality assurance and quality control are two parts of the quality management system. While quality control is reactive and focuses on specifics like ensuring product performance through testing and inspection, quality assurance is more systemic. It focuses on the product design to development, delivery and retirement process, preventing deviations and errors in the manufacturing process. This minimizes the risk of nonconformance and continuous improvement of quality management to ensure product quality, performance, and safety.
With quality assurance, businesses assess how well the standard operating procedures are implemented and executed, whether these processes are healthy and effective, and deliver on promise. This focus on process ensures that the end product is of the desired quality, conforms to the specifications, is compliant, and results in desired outcomes.
Quality assurance is a process with many steps to prevent flaws from entering the system. The aim is to identify risks and implement controls and continuous improvement to minimize deviations and potential errors. It ensures compliance with relevant regulatory standards and requirements such as ISO and FDA, as also the internal standards and policies.
The effective implementation of quality assurance is ensured through what is commonly called as the Plan-Do-Study-Act Cycle. It is an iterative process that begins with a plan for quality improvement, actualizing the improvement process, assessing its effectiveness, and acting based on the feedback to start the next cycle of improvement.
Along with the PDSA Cycle, quality assurance teams also use testing to monitor the manufacturing process and ensure it meets all the requirements. This helps to determine and flaws in the product at an early stage, correct them, and decrease defects over time through constant process improvement.
Quality assurance can happen at 4 stages:
Four processes that help ensure QA include:
Audits: Audits are scheduled and conducted to verify whether manufacturing procedures comply with internal standards and regulatory requirements.
Defining Processes: A process is defined and detailed to provide clarity at the time of testing to ensure the delivery of consistent results.
Identifying and Selecting Tools: The right tools must be chosen to test products and they must be calibrated often for reliable results.
Training: Quality is an enterprise-wide activity with contribution from every team member. Providing training in aligning tasks to quality SOPs and following protocols is critical to ensure proactive approach to quality. Identify gaps and provide suitable training to meet quality needs.
The direct benefit of a good medical equipment quality assurance process is the continuous improvement of quality product performance, and safety. There are some significant and indirect benefits too. These include:
Lower Manufacturing Costs: As the quality of processes improves, so does efficiency, productivity, and resource utilization. This results in lower costs of manufacturing, larger savings, and greater innovation.
Risk Reduction: Constant monitoring of the quality and performance of processes and product help identify potential risks and take mitigative action to minimize damage and errors.
Improved Customer Satisfaction: Enhancing the quality of manufacturing process improves the quality of the product. Quality assurance ensures that the product performs as expected, helping customers with their healthcare needs and providing satisfaction. This helps with building the brand reputation and accelerating growth. It also helps with innovation and value addition, thereby improving customer delight.
One of the primary requirements for a medical device manufacturer is to meet regulatory needs. A robust medical equipment quality assurance (QA) ensures compliance and establishes a culture of quality that goes beyond compliance. Quality integrates with all processes and incorporates proactive and preventative aspects, reducing issues and improving product performance.
It also protects patients and healthcare workers using the product from potential harm. Constant improvement and innovation improves the product quality and performance, thereby increasing customer delight.
It helps with risk management and minimizes the possibility of potentially harmful devices from entering the market.
It brings down the risk of warning letters and recalls. This, in turn, protects businesses from financial losses due to rework and the damage to reputation.
Integration of quality workflows with operations enhances visibility into processes and facilitates automation, further reducing errors and risks. Cloud-based quality assurance systems also enable businesses to manage quality even in remote sites and empower workers across locations to align their processes with quality procedures. It helps create a culture of quality with proactive resolution of issues.
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