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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
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At ComplianceQuest, we published a Whitepaper titled ‘Design Controls in the MedTech Industry. In this paper, we highlighted the importance of the following:
To know more, download the Whitepaper here: https://www.compliancequest.com/whitepaper/design-controls/
The product development lifecycle typically covers:
A Design Controls traceability matrix becomes crucial for the product development teams to understand the relationship and linkages between all these aspects of the development cycle.
The design control traceability matrix is an industry best practice that provides a high-level view of the flow of medical device product development from start to finish. It is also a requirement in ISO 13485:2016.
While in the initial stages, a traceability matrix might be maintained in manual tools such as Excel. But as the complexity increases, it can become impossible to track. Using an automated, cloud-based solution such as ComplianceQuest can improve speed, efficiency, and reduce risk.
Before the development of a medical device, it is essential to define two key factors:
This requires an understanding of the User Needs, which should be documented along with how the medical device under development is going to be used. To help you better understand User Needs, you need to answer questions such as:
The answers form the foundation for development of the product as they help understand User Needs and are part of Design Controls. Once the User Needs are documented, the next step is to formalize the Design Inputs.
Design Inputs can be understood as the specifications that establish the features and the performance criteria of the device. Design Inputs are derived from User Needs, which can be subjective and abstract. So Design Inputs must be drawn out and converted into be objective and measurable specifications. They should also take into account industry standards, competitive products, and regulations and take into consideration factors such as:
The clarity emerging from these questions will improve the process of establishing the design inputs.
Design Outputs determine what the product will eventually be, containing granular details about all the components and subsystems that will go into the making of the product. Drawings, specifications, and instructions are the components that make up the design output. This should demonstrably link back to design inputs and is the Device Master Record for the product.
Design Verification helps to verify whether the medical device meets design inputs. Design Verification is a vital step in the process, but it can be expensive and time consuming. Therefore, having a clear-cut plan with specified budgets for time and cost is crucial. So it is important to:
While Design Verification establishes the correctness of the design of the medical device, Design Validation proves that the correct medical device has been designed. In other words, it establishes that the medical device meets user inputs and that it will meet intended uses and indications of use.
Design Reviews should be conducted periodically throughout the design process. These meetings help in identifying gaps and correcting them in a timely manner to prevent more costly corrections later. Design controls should also be a part of the Design Review. While the number of design reviews may vary from product to product, a final design review must be conducted before moving on to the next phase of the design and development process. Once the design has been finalized after the design validation stage, the design transfer to production happens. At this stage, the traceability matrix can be closed too.
To ensure that the design process deliverables are performing as expected, the following should be reviewed periodically:
FDA Design Controls regulations and ISO 13485:2016 require a Design History File to be maintained. It is a record of all the Design Controls, made accessible to the project team. It establishes the linkages and relationships between all the Design Controls and demonstrates the traceability of all the Design Controls throughout the product development process. It should be readily available for regulatory inspection as well and should be kept up to date and current.
Implementing Design Controls poses several challenges. Some of these include:
Overwhelming Documentation
Collaboration Across Departments
Numerous Changes & Updates
Managing Risks
A cloud-based Product Design Management Solution from ComplianceQuest can help businesses manage design controls better and overcome the challenges. The solution is integrated with the CQ EQMS, thereby providing instant access to risk management and documentation solutions, among others.
The 5 key features of the CQ Design Controls software include:
With CQ’s Product Design Management Solution, customers can bring their products to market quicker by gaining 100% visibility and traceability of the product development process. CQ makes collaboration easier, offering design teams better control over design inputs, requirements and risks to improve product quality while ensuring compliant documentation.
The benefits include:
Collaboration Simplified: For all members with meeting minutes, action items, and more
Single View: A unified view of all requirements, inputs, outputs validations, and verifications
Compliance: Ensure proper documentation in compliance with ISO 14971 and FDA CFR 820
Efficient: Decrease the time and labor needed for design projects
100% Traceability: Track and access records of changes, reviews, validations, and verifications
Embedded Risk Management: For all product-related risks along with proper risk control
Unified Repository: For all design documentation easily accessible to all members
Always Up-To-Date: Design files with change alerts to ensure proper change implementation
Easy Publish: Print design data, documents, and records with one-click at any time during development
These features closely align with the design and development process and are fully compliant with FDA and ISO requirements. In addition to enabling designers to automate design controls, they can also leverage the CQ EQMS features such as document, change, CAPA, and management review. This further ensures the quality and safety of the design and helps to meet user and indications of use requirements.
To know more about ComplianceQuest Design Controls, request for a demo: https://www.compliancequest.com/online-demo/
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