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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
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
Design Quality
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
Complaints Management
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
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
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
Risk Management
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
Supplier Management
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]
Safety Management
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
Environment and Sustainability
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
Self-guided Product Tours
Product Demo Videos
Pricing
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.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
About
About ComplianceQuest
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.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
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Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
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Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Technological development and breakthroughs in medical research have enabled medical technology companies to develop pioneering therapies and treatments for several diseases. The blurring of lines between hardware and software also makes many of these solutions compact and portable, increasing the ease of use for patients and caregivers.
But, these developments have also given rise to other, newer challenges. On the one hand, regulations have become more stringent to protect patients and their privacy. On the other hand, MedTech companies are also grappling with issues such as rising costs, time to market, increasing competition, and quality control.
Regulatory requirements make design controls, requirements traceability, and product risk management mandatory. This is to ensure that the product meets the specifications and fulfills its purpose while ensuring patient safety. Businesses minimize the chances of receiving warning letters or product recalls by complying with Food and Drug Administration’s Sec. 820.30 regulations and other similar standards and regulations. These regulations cover the entire aspect of design and development from planning up to the point of transferring the design to manufacturing.
The regulations require the design to be reviewed at every stage from the time of planning the design of the device to input gathering and to the final output. This ensures that the design still conforms to the initial plan and purpose even after the changes it undergoes at different stages of the design lifecycle. The changes must be documented and approved and all references stored in a design history file for easy traceability and to demonstrate conformance to requirements.
Sec. 820.65 Traceability of FDA specifies the need for manufacturers to establish and maintain procedures that enable the identification of implants and similar devices with a control number for each unit, lot, or batch of finished devices, and appropriate components where required. This is to enable corrective action and the identification should also be documented in the design history file.
While these improve patient safety and product quality, they also make the process more complex for manufacturers.
The MedTech companies have their plates full with a plethora of challenges including:
In a manual design controls process, keeping track of the many aspects that go into the design and development of the product can be difficult. Documentation and tracking can be a drain on resources and the lack of visibility can lead to errors being introduced unwittingly. Gathering relevant information and leveraging it effectively for continuous improvement may also not be possible.
Using a quality management system such as ComplianceQuest can help manage the design controls workflow end-to-end, providing visibility and facilitating proper documentation. The Product solution from CQ enables the automatic creation and updation of DHF and DMR with the latest approved documents and design files.
It can help teams connect and collaborate in real-time, enabling better change management and document sharing to minimize deviations and errors. Reviews and revisions can also be speeded up and made more accurate, reducing non-conformance.
All stakeholders can access centralized data sources and a unified repository for all design documentation including requirements, deliverables, and changes. It can also be integrated with product data from other sources such as ERP and Jira, thereby providing a holistic view of all documents with appropriate access controls.
The CQ platform also improves project management, which allows tracking of actions, deliverables, and timelines for improved productivity and compliance.
CQ Product facilitates requirements traceability and product risk management by allowing the teams to track and manage the design lifecycle including design inputs, outputs, validations, and verifications along with integrated management of product risks. This can help improve product quality, and meet regulatory requirements while ensuring patient safety.
To know more about ComplianceQuests Product Solution, watch this demo video: https://www.compliancequest.com/demo-video/product-design/
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