Design controls are processes and procedures implemented by medtech developers to ensure that their products are designed and developed in a systematic and controlled manner, including design planning, verification and validation, risk management, and design transfer, to see that products meet quality and regulatory requirements. Mature design controls are processes, procedures, and guidelines that establish consistency and quality in product design and development that are very beneficial for documentation, verification and validation, risk management, change control, and design reviews that help medtech developers with faster time to market and compliance with regulatory requirements to avoid costly penalties.
A few key terms related to design control that can be easily confused: Design History Files (DHF) provide a comprehensive history of medical device design and development and assure regulatory authorities that the device has been developed in accordance with regulations and standards. Device Master Records (DMR) contain all the necessary information and specifications for the production and control of a medical device, such as device specifications, manufacturing processes, quality control procedures, labeling requirements, and any other relevant information related to the manufacturing and control of the device. Device History Records (DHR) show a complete history of the production and control of a specific batch of medical devices, including production records, inspection and testing results, packaging and labeling records, and any other relevant documentation, to verify regulatory compliance and track the quality and traceability of each individual device.