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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
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Strategically manage the complete lifecycle of your product
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
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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
Optimize product development and compliance with FDA Design Control, transforming your processes to meet regulatory standards while fostering innovation and quality excellence.
Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design control make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. Design controls intend to increase the chances of transferring the design to production, without much difference, into a device suited for its intended use.
Design controls for medical devices demonstrate the safety, effectiveness, and usage indication. The FDA design control guidance applies to
The FDA design control guidance discusses subjects in which they appear in the FDA’s Quality System Regulation. It is cross-referenced to International Organization for Standards (ISO) 9001:1994,Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and the ISO draft international standard ISO/DIS 13485, Quality Systems Medical Devices Particular Requirements for the Application of ISO 9001, dated April 1996.
The product development cycle refers to the various stages involved in the product life cycle, right from design and development…
The ComplianceQuest Design Control and Product Lifecycle Management solutions are designed to bring higher quality products to market faster with…
Technological development and breakthroughs in medical research have enabled medical technology companies to develop pioneering therapies and treatments for several…
FDA design control provide managers and designers with improved visibility of the design process. With improved visibility, managers can direct the design process more effectively by recognizing problems earlier, making the necessary corrections, and modifying resource allocations. Designers benefit from the design control process as there is an enhanced understanding of the degree of conformance of a design to the user and patient needs, leading to improved communications and coordination among all participants in the process. The design and development planning is based on section 820.30(b) of the FDA guidance. The guidance requires:
Every manufacturer to establish and maintain plans describing the design and development activities. The manufacturer must also define all responsibilities for implementation.
The plans to be used to identify and describe the interfaces with different activities or groups involved in the design and development process.
The plans to be consistently reviewed, updated based on inputs, and approved as design and development evolves.
FDA 21 CFR 820.30 defines the various FDA clauses as part of FDA design control. They are
General
A basic procedure of the design control process is drafted using questions focusing on process definition, implementation, and documentation.
Design and development planning
During the planning stage, various aspects such as logistical coordination, clearly defined responsibilities of team members and contractors are finalized. This stage also defines the timeline which sets the project pace, teams to be hired, and any future activities that need planning.
Design input
Design inputs focus on three requirements namely functional, performance, and interface. Design input is an important part of Subpart C of the QSR that defines all product and market specifications, including the needs of the market, and the consequent effects of each aspect of the product.
Design output
Design output should act as a manuscript listing all the components used in medical devices. It is a document that will be given to manufacture the device and its necessary components. When compared to the design input, design output must be tested for conformity. Design output should include all physical and numerical design aspects and must be recorded in the Device Master Record.
Design review
Design reviews are conducted at strategic points during the design process. Design review is aimed at keeping the project focus, share feedback on the designer on potential issues, and act as a checkpoint before moving to other project aspects such as materials, software, techniques for construction, electronics, pneumatics. The results of a design review is stored documented in the form of a design history file (DHF) that includes details such as design identification, date, and name of the individual conducting the review.
Design verifications
Design verification gives designers the freedom to showcase and prove that the device meets the exact product specifications. This stage continues through the development process as various components are tested to confirm that the device is built as planned. Design verification focuses primarily on the product specification while validation is about market specifications such as user needs, guidance documents, standards, among others.
Design validation
Design validation focuses on the market specification to confirm it has been met. To do so, the product is put to test in the expected or stimulated environment to understand the performance. There are two kinds of validation, namely process, and design validation. Once validation is completed and the product becomes ready for production, the manufacturer must create a plan to execute proper mass manufacturing. This next step is called design transfer.
Design transfer
Once the device is ready for production, proper instructions must be given to ensure the device is produced by following all the instructions acquired through documentation, training, and computer programs. To avoid mishaps, all instructions should be clear and thorough so that any unforeseen change in personnel or machinery can be dealt with using the instructions.
Design changes
Design changes must be controlled through two different components: document control and change control.
Design history file
The design history file is the pinnacle of design controls. It is a formal document prepared for every medical device to include all the required documents from early stages of production. It is an organised account of the product’s manufacturing process. The main purpose of the file is to showcase that the team followed the design plan and all of the requirements were fulfilled.
While using design control process guidance, manufacturers must focus two aspects:
As Design Control focuses on correcting design errors early in the design and development process, organizations must focus on having a written design control system to understand the requirements while also having a baseline to review the system to periodically review for improvements based on problems, history, and previous failures of the system. Before setting up the design control process guidance, three important definitions must be clearly understood.
Once the definition is clear, follow the design control guidance for medical device manufacturers as discussed below.
Clearly define user needs specifying how the device is expected to meet their requirements
Design and develop a plan that details the team’s efforts to handle Design Control during the development process
Describe the design inputs that describe the specifications of the product based on user needs
Document the design outputs, specifically design, materials, and components needed to build medical devices in the form of drawings and diagrams
Conduct and sign off design review that helps evaluate design requirements at various stages of development
Test the product as part of design verification to prove that the device works as intended
Perform a design validation test to check if the device meets the user needs as defined earlier
Focus on design transfer or design production with the actual process of producing a medical device
Applicable to the entire lifespan of a medical device, the design change is about revisions that may be needed to the product
Design and develop a plan that details the team’s efforts to handle design control during the development process
We conducted a thorough, comparative review of systems within our budget and CQ was a clear winner. The system is powerful and versatile, even with an out of box implementation. The functionality is complete, covering every significant aspect of a quality system. Validation is straightforward with the use of OQ scripts from CQ, which can be modified to fit your implementation. It ensures that processes implemented through the system and records generated by the system are compliant for medical device companies. But, the biggest benefit we’ve received is through the collaborative partnership with CQ personnel. They listen and understand our needs. They are creative in helping us make implementation as easy as possible. Having been in large companies and small, I can see this system fitting in either environment and budget.
Jackie Jaskula,Director of QA and Regulatory
9 Must-have Checklists for Effective Product Design Management
Checklist | January 27th, 2023
Understanding Design Controls “Input & Outputs” Requirements
Checklist | August 17th, 2022
Complying with the Regulatory Requirements During Design and Development Stages
Assessment of the Core Activities of Design and Development
Checklist | August 3rd, 2021
Helps employees understand the requirements, process, and expectations of design
Assures the quality of design
Acts as a baseline to review the system periodically for further improvements
Improves the chances of a design approved for production translating into a device relevant for its intended use
Improves design process visibility
Design controls
Supplier management
Risk management
Document control and records management
One of the major problems businesses face with regards Design Controls – overwhelming Documentation. From 1983 to 2017, the number of pages in design files for a 510(k) submission increased by more than 2,000%. Extensive documentation can inhibit efficiency, leading to delays, mistakes and non-compliances. For teams using paper systems, or spreadsheets maintaining proper documentation including signatures and revisions can quickly become a nightmare. This is where a cloud-based document management solution comes into play. CQ Document Management helps manage the entire document lifecycle, gain complete visibility, improve design control and rely on a single source of truth across all locations for more effective decision making. The solution can be used to gain better understanding of the design process and document changes for future reference and compliance.
Boost productivity and efficiency with a workflow-driven process that emphasises on having complete transparency in the design process
Manage all the documents in your workflows within a single system that can help with FDA design compliance, registration and surveillance audits, CAPA escalations, non-conformance, change control, and customer complaints
Eliminate separate legacy document silos that can hinder the deisgn process with a single enterprise-wide system to improve collaboration
With easily accessible documents and workflow capabilities tightly coupled with CQ’s Training functionality, ensure employees are notified when CAPA-driven processes or work instructions change, and effortlessly track that all appropriate reviews have occurred
Always have access to the most recent set of approved procedures, designs, and best practices
The ComplianceQuest Design Control and Product Lifecycle Management solutions are…
The journey to manufacturing a product is filled with several…
One of our clients, a medical device manufacturing company, was…
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