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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
A medical device company specializing in neurostimulation technology for a non-opioid approach to pain management realized that their CRM, inventory management, and Quality Management were disconnected from each other.
This lack of data visibility and seamless flow of information across business systems reduced both productivity and operational efficiency. The company’s business leaders were unable to leverage critical data (at the right time) which undermined their growth strategies.
Additionally, the inefficiency spilled over to complaint processing as well, and though sales volume was growing, the company was falling behind on resolving complaints.
This was because the complaints were tracked manually, which made it challenging to keep up with every detail. Each complaint submitted was touched by several stakeholders across quality and compliance, engineering, sales, and R&D teams — which prompted the need for a more collaborative and connected solution.
The lack of an integrated complaint management system also made it difficult to initiate a CAPA or a root cause analysis (RCA) process. In cases where the root cause of the complaint was due to a supplier quality issue, the process of handling the complaint became more complex. While the company prided itself on delivering high levels of patient satisfaction, it was critical to upgrade and automate complaint handling.
Streamlining the complaint management process became extremely important to fix issues on time, proactively mitigate risks, increase brand reputation and drive growth.
Inefficient complaint management is a problem faced by most medical device companies. The only way to do this right is to automate the entire quality management workflow where processes, people, and systems are truly connected. The complaint management module has to be integrated with the rest of the business processes.
In this post, we look at how medical companies are embracing automation, digital transformation, and next-generation technologies to build a world-class complaint handling workflow. More specifically, leaders in the medical device industry are deriving intelligence from complaint data to proactively mitigate risks, spot opportunities and improve their overall product.
Business leaders in the medical device industry often point out that every complaint is different. One needs a system that does automatic triaging of complaints based on risk level and urgency.
Additionally, end-to-end management of complaints driven by a seamless flow of information across the enterprise is a “must-have”. ComplianceQuest’s Complaint Management System automatically queues all complaints that require further triaging to be reviewed by the relevant complaint coordinator.
By taking advantage of data and Artificial Intelligence framework of Einstein Predictive Analytics, complaint handling teams can automatically triage complaints based on risk level and urgency. Following the triage, a complaint is routed for further investigation and evaluated for the need to report to a regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the complaint’s severity and priority.
Manual and legacy systems that operate in silos are extremely inefficient and ineffective when it comes to managing complaints. One needs a next-generation solution that is truly integrated with the end-to-end product lifecycle. Right from intake of complaints to regulatory submissions to complaint resolution, one needs to take advantage of automation.
An effective solution is one that will drive continuous improvement of the entire workflow, ensure all regulatory requirements are taken into account, and proactively work to minimize risk.
The aforementioned medical device company opted for ComplianceQuest’s Complaint Handling Software, for five key reasons:
These were all key features that increased overall efficiency of the complaint management process.
Be it FDA 21 CFR 820.198, ISO 13485:2016 section 8.2.2, MDR or MDSAP, all regulatory standards require medical device companies to establish a process for complaint handling – right from intake to resolution.
Regulators demand that clear procedures are established for the following:
Regulations are stringent even for software-based medical device companies. One of our customers, a software medical device manufacturing company headquartered in Miramar, Florida, was founded as a collaboration between the Red Cross and One Blood. Their software tracks each unit of donated blood from collection to transfusion, streamlining the complete blood donation process for quality and safety.
From day one, it wanted an FDA-compliant business and opted for ComplianceQuest’s EQMS software for its flexibility, scalability, and in-depth experience in medical device quality management.
Our Complaints Module offered a reporting feature that fit with the client’s needs perfectly. The module provides best practices for life sciences combined with decision tree functionality, which supports the identification of adverse events and report types by various regions. This unique, out-of-the-box feature helps the company determine if an event is reportable, provides a form to fill in details need by the FDA, and automatically creates the XML file to load into the FDA’s reporting system once done. This is the kind of automated reporting that medical device manufacturers are looking for.
A NASDAQ-listed high-tech medical device company that designs, develops, manufactures, and markets advanced silicone-filled breast and body shaping implants, has offices across Brazil, Belgium, and the USA. It markets and sells its products to physicians, hospitals, and distributors in over 80 countries across the globe.
Founded in 2004, the company began with a paper-based quality management system to establish the core of its quality process. But by 2017, it realized that it needed a more robust and scalable Quality Management System (QMS) if the company had to maintain its quality as it grew rapidly. With a manual system, tracking of quality metrics and visibility into operations (including complaints handling) became complex.
The quality leaders at the company quickly realized that a single complaint may not be a reflection of just one unit of the product. Rather, it may have an implication on an entire batch. They also realized that data from complaints provided access to much needed intelligence. If the company could garner insights from complaint data and take action as needed, it would help them proactively address quality issues ahead of time.
It is an opportunity to drive continuous improvement and, therefore, needs to be documented and shared across the supply chain. The impact of the change being made also needs to be analyzed for risk and any other complexity that may arise. This needs a view into the end-to-end product lifecycle and that is possible only with a next-generation solution such as the one from ComplianceQuest.
For any business, having a well-designed process for not only for complaints handling but also gathering insights from complaints data will be a game-changer.
For a more detailed perspective of the complaints management process and how to use the power of automation and digital transformation better, download this Whitepaper titled “Getting Complaint Management Right : Automation and Collaboration hold the key” here: https://www.compliancequest.com/whitepaper/getting-complaint-management-right/
Businesses can manage their complaints workflow from intake to remediation and continuous improvement using ComplianceQuest’s Complaints Management solution:
To request for a demo our offering, click here: https://www.compliancequest.com/online-demo
“We implemented ComplianceQuest (CQ) to replace our previous Complaint Management System. From the very first day, CQ went above and beyond to help provide expertise on how to automate our business processes, providing insight into how to properly migrate data to CQ, all while ensuring that our new processes were FDA compliant. They worked day and night to ensure our requirements were met”
- VP of Quality at a leading medical device company
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