Cloudtheapp Inc., a leading provider of configurable quality management and regulatory compliance software solutions, is excited to announce the release of its newest module: Design Controls. This latest addition to Cloudtheapp’s suite of products is specifically tailored to the needs of the medical device industry, providing a comprehensive platform for managing the design and development process of medical devices in compliance with regulatory requirements.
The Design Controls module enables medical device manufacturers to create, manage, and track all aspects of the design control process, including user needs, design inputs, design outputs, verification and validation, risk management, design changes, and design reviews. This module is fully configurable and adaptable to the unique needs of each business, providing a flexible and efficient solution for managing the complex and ever-evolving landscape of regulatory compliance in the medical device industry.
Cloudtheapp’s new Design Controls module introduces several important features that can help medical device manufacturers streamline their design control processes and comply with regulatory requirements.
Firstly, the module includes a Risk Management tool that allows manufacturers to identify and assess potential risks associated with their products, and to develop strategies to mitigate those risks. By introducing risk management as a key component of the design control process, the module helps drive design improvements and ultimately leads to safer and more effective products.
Secondly, the module includes a Traceability Matrix Auto Generation feature, which automatically generates a traceability matrix that links user needs, design inputs, design outputs, and verification and validation activities. This feature streamlines the process of documenting the design control process and ensures that all activities are linked and accounted for.
Finally, the module includes an Automatic Generation of Design History File feature, which generates a comprehensive and up-to-date Design History File (DHF) for each medical device. This feature ensures that all design control activities and documents are properly documented and managed and that the DHF is complete and up-to-date for regulatory inspections and audits.
“By incorporating these three key features into our Design Controls module, medical device manufacturers can have a powerful tool that helps them govern their design control processes in a holistic and compliant manner,” said Wael Zebdeh, CTO of Cloudtheapp. “These features are designed to streamline the design control process, improve the quality of products, and ensure compliance quality standards and regulatory requirements across different countries”
With the release of the Design Controls module, Cloudtheapp continues to demonstrate its commitment to providing cutting-edge software solutions that help businesses simplify and streamline their regulatory compliance processes. By digitalizing the design control process, medical device manufacturers can ensure that their products meet the highest quality and safety standards, while also reducing the time and cost associated with traditional manual processes.
Design Controls are a critical component of quality management in the medical device industry, and are essential for ensuring that products are safe and effective for their intended use. The purpose of design controls is to establish a systematic approach to product development that ensures that all aspects of the design process are planned, documented, and controlled to meet the requirements of the product. By implementing a comprehensive design control process, medical device manufacturers can identify and mitigate potential risks and hazards associated with their products, ensuring that they are safe and effective.
The ISO 13485 standard requires medical device manufacturers to establish and maintain a documented quality management system that includes a comprehensive design control process. The standard specifies that the design control process must include the identification and documentation of design inputs, design outputs, and design reviews, as well as the evaluation and control of design changes. The purpose of these requirements is to ensure that the product design is clearly defined and documented, that it meets the requirements of the intended use and user needs and that it is thoroughly tested and validated before it is released for production. By adhering to the ISO 13485 standard and implementing a comprehensive design control process, medical device manufacturers can demonstrate their commitment to quality and safety, and ensure compliance with regulatory requirements in the markets they operate in. This ultimately leads to improved patient outcomes, enhanced customer satisfaction, and increased confidence in the safety and effectiveness of medical devices.
Design Controls are a regulatory requirement for medical devices in many countries, and the US FDA is no exception. In the US, medical devices are regulated under Title 21 of the Code of Federal Regulations, specifically under Part 820, which outlines the Quality System Regulation (QSR) for medical devices. Within Part 820, section 820.30 requires medical device manufacturers to establish and maintain procedures to control the design of their products.
According to Said Nobani, CEO of Cloudtheapp, the Design Controls module is a crucial addition to Cloudtheapp’s configurable Quality Management and Regulatory Compliance software solutions. He emphasized the importance of having the module fully integrated with other aspects of the Quality Management system, as it sits on the same platform.
“Integration is key to achieving a streamlined and efficient Quality Management system, and our Design Controls module is fully integrated with our other modules, such as Document Control, Change Control, and CAPA Management,” said Nobani. “This integration enables our customers to manage all aspects of their Quality Management system from a single platform, improving efficiency, reducing errors, and ensuring compliance with regulatory requirements.”
Nobani also highlighted the module’s ability to adapt to the unique needs of each customer. “Our Design Controls module is highly configurable, allowing each customer to tailor the module to their specific needs and processes. This flexibility ensures that the module can be easily integrated into their existing Quality Management system, and that they can comply with regulatory requirements in a way that works best for them.”
The Design Controls module is powered by real-time analytics and dashboards, which provide users with the ability to visualize data and gain insights into quality and compliance trends. The module is designed to capture and track data throughout the design control process and present that data in an easy-to-understand format.
The dashboards and analytics in the Design Controls module allow users to track the status of design inputs and outputs, the progress of verification and validation activities, and the status of risk management activities. By visualizing this data, users can gain insights into their design control process, identify areas for improvement, and track progress over time.
Cloudtheapp’s new Design Controls module is built with the customer in mind, offering a drag-and-drop designer tool that allows users to reconfigure all aspects of the module without the need for coding or technical knowledge.
The innovative designer tool empowers users to quickly and easily configure the Design Controls module (as well as any other module) to meet their specific needs and requirements. With this tool, users can easily modify workflows, forms, and other aspects of the module to ensure that it fits seamlessly into their existing processes.
The designer tool is part of Cloudtheapp’s overall approach to providing configurable software solutions that can be tailored to meet the specific needs of each customer. By offering this level of flexibility, Cloudtheapp can help customers achieve their goals more quickly and effectively, without the need for extensive coding or technical expertise.
The new Design Controls module is available now on the Cloudtheapp Store and can be downloaded with just a click of a button. We are proud to offer this innovative module to our valued customers, and we are confident that it will provide a powerful tool for med device manufacturers and others in need of quality management and regulatory compliance solutions.
At Cloudtheapp, we are committed to providing the best possible software solutions to our customers, and we are confident that the new Design Controls module will help businesses achieve their goals more efficiently and effectively than ever before.
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