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Design Process and Quality System Development Tools in Product Lifecycle
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Design Quality: Connecting Design to Documentation
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Challenges with Triage and Investigation in Complaints Management Process
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Manufacturing Challenges and Industry Trends Towards Digital Transformation
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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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 quality, safety and efficiency as they bring their products from concept to customer success.
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Recently, ComplianceQuest published a nuanced whitepaper on “Integrating Quality Compliance into the Product Design and Development Process using CQ’s Design Control Solution”. The paper focuses on –
In this blog, we focus on the growing importance of design controls in the medical device industry and the role it plays in the product development lifecycle. We also discuss if automation will help resolve some of the key challenges businesses face while developing a product.
Design and development of medical devices or MedTech products is a complex process. It requires deep collaboration between three critical teams:
The product development lifecycle is a multi-step process including brainstorming product requirements, developing the product prototype, collecting design feedback, product testing, and successfully transferring the product to production.
Given the sensitive nature of its use, medical devices also come with their own set of risks that need careful monitoring. A medical device manufacturer must ensure the product is effective and safe to use.
This is where design controls come into play. Except lowest-risk medical devices, the Food and Drug Administration (FDA) mandates manufacturers to develop their medical device under design controls.
Without an automated solution to manage design controls, the whole process becomes very challenging and difficult to track.
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)”.
Design controls enable integrating a systemic approach to design during the product development lifecycle to:
Broadly, using design controls during the product development lifecycle offers the following six benefits —
Today’s medical device industry is continuously growing. As businesses scale, it becomes difficult to rely on paper-based systems to document the design process or a digital file to track design changes. Similarly, the Safe Medical Device Act introduced Design Controls to regulate the design process for certain classes of medical devices in a better way. Compliance with regulatory standards and the complexity of the design process need robust software.
The design and development of medical devices is a complex process, with the chances of incurring high costs and wastage of resources being high. This has made digitizing and automating essential to improve efficiency, lower costs, and optimize resources.
ComplianceQuest’s Design Controls Solution gives you complete visibility over your product design process, making it easy for your teams to collaborate and design high quality products, while guaranteeing compliant and comprehensive documentation.
The solution ensures that the medical device developed is compliant with user needs, its intended use, and other specific requirements and prevents unexpected problems. Designed to align with regulatory requirements, the ComplianceQuest’s Product Design Management Solution helps businesses improve product quality, lower the cost of quality (CoQ), and maintain regulatory compliance – across the design lifecycle of medical devices.
Built on the Salesforce platform, the solution is integrated with the ComplianceQuest EQMS, thus offering instant access to risk management and documentation solutions, among others.
The key features of the CQ Design Controls Software include:
Our Design Controls Solution along with our Requirements Traceability and Product Risk Management Solution can be true game changer for engineering, product, quality and business teams in the MedTech sector.
To see our product in action, request a demo here:https://www.compliancequest.com/lp/design-control/
Watch a 6-min demo video here: https://www.compliancequest.com/demo-video/product-design/
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