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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
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When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
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Efficient Waste Management for Compliance & Sustainability
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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
Intel’s Andy Grove famously said, “Only the paranoid survive.” Of course, he said this in the context of how the world’s leading chip maker, Intel, had to reinvent itself in the face of competition from Japanese chip makers who were able to manufacture hi-tech chips at lower costs and with better quality. Yet the statement holds true in almost any scenario.
In sectors like medical device manufacturing, it is absolutely critical to design and manufacture products that are safe, effective and of high-quality. The Food & Drug Administration (FDA) in the US, the European Competent Authority in Europe, Health Canada in Canada and other similar agencies across the globe require medical device companies to comply with stringent rules and regulations. Not only do these regulations govern the end-product but also the product design & development process, called Design Controls.
The development of medical device products is complex, can take years of development and millions of dollars as investment. Teams are under pressure because a seemingly small problem with one mechanical component, or a mistake in one line of software coding, can lead to catastrophic product system failure.
In this guide, we highlight the challenges faced by engineering and quality leaders when it comes to compliant design controls. The paper throws light on how using a cloud-based, next-generation platform to automate design controls – right from capturing user needs to implementing a design change - can help with:
The Food and Drug Administration1 (21CFR 820.30) defines Design Controls as:
“a set/framework of quality practices and procedures incorporated into the design and development process of a medical device product to assure that device specifications meet user needs and intended use(s)”.
Bring higher quality products to market quicker with full compliance and comprehensive documentation.
Help your quality and engineering teams stay in sync with a single source of truth for all your product design activities with CQ’s Design Controls Solution.
To know more, visit: https://www.compliancequest.com/design-controls/
Design controls enable integrating a systemic approach to design during the product development lifecycle to:
With early correction of designs, rework can be minimized, costs kept under control, and resource allocation improved. This ensures the performance,quality and regulatory requirements of the product are met. It also helps increase design conformance to user needs while improving collaboration and coordination between the different stakeholders.
The other key feature of design controls is its integration with risk management, engineering, and quality assurance.
Why Automation of Design Controls is Critical: Robust documentation, data visibility and vigilance are key to protecting patients and users from flaws in design. With automation, it becomes easier to identify, track and monitor the checks and balances needed to instil quality and compliance into the design process.
Meeting Regulatory Requirements: The FDA (21CFR 820.30) requires that all Class 2 and 3 medical devices establish (Define, Document & Implement) and maintain (Review, Approve, Update) procedures to control the design of medical devices.
Medical Devices are on the rise: With technological advancements, more medical devices are emerging and playing a major role in the health of patients. (For instance: Apple Watch is now considered a Class II medical device)
In today’s uncertain world, risk management has become critical. I That’s why automating the process of identifying, analysing, controlling, and monitoring risks is key to designing high quality products.
Risk management should be an integral part of the product development cycle right from the time of documenting user needs. As the design evolves, so will the risks, which need to be identified and managed at every stage. As new risks manifest, putting appropriate controls can make the product more robust and improve its quality and safety.
Traditionally, in the waterfall model, the product development process was sequential. The engineering department would first design the product, which would then be transferred for production. Other departments or organizations would get involved based on the process flow. As a result, the gap between the design and the end product would be vast, requiring rework, redesign, recall, wastage, etc. This would lead to excessive costs as well as delivery time implications.
As businesses move towards an agile or concurrent development model, the process flow has changed and collaboration between all teams happens right from the design stage. The product is reviewed at every step of the product development process, thus reducing development time, controlling costs, and ensuring improved product quality.
In this approach, the line between development and production blurs. Design control becomes crucial as design enters the development stage before being completed. Therefore, it is essential to have a comprehensive matrix to track every component, process design, and the product.
In short, it is critical to understand the linkages and relationship between User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.
The third aspect of design controls is that it is closely integrated with the quality system underpinning the product development lifecycle, covering design, production, distribution, use, maintenance, and obsolescence.
A quality policy document is required to guide the processes associated with design controls.
Establishing a quality policy is an essential part of device development as it defines the processes and procedures that will guide compliance. Design controls are a part of this quality system and come into play from the time of developing and approving design inputs, to the design of the device and its production. The other three parts of the quality system are risk management, document control, records management, and supplier management.
But it does not end there. It still plays an essential part in any changes introduced to the device or the manufacturing process,, even after the product has been released. Changes could include new features, updated functionalities or correction of any causes of failure. It is an essential part of continuous improvement and being able to meet customer needs.
Therefore, design control is not a one-time task, but a lifelong process.
For more information on CQ Design Controls Solution, visit: https://www.compliancequest.com/design-controls/
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