Design Control is a fundamental requirement set forth by the FDA, detailed in 21 CFR 820. It forms the cornerstone of the quality system that medical device companies in the United States, or those planning to market their products in the U.S., must establish for the design and development of their medical devices. This webinar will provide a comprehensive overview of Design Control, illustrating its importance.
Viewers will learn about the essential elements of Design Control, including design planning, input and output specifications, design verification and validation, risk management, and design reviews. The session will demystify the regulatory requirements, explaining how each component fits into the overall quality system framework and contributes to ensuring the safety and effectiveness of medical devices.
Nelson Labs’ expertise in supporting sponsors with Design Control requirements will be showcased, demonstrating how their services can help streamline the design and development process. From initial design inputs to final design validation, Nelson Labs offers comprehensive support to ensure that medical device companies meet all regulatory requirements efficiently and effectively.
By the end of this webinar, participants will have a solid grasp of Design Control principles and practices, enabling them to establish robust quality systems that comply with FDA regulations. This knowledge is crucial for design teams, quality assurance professionals, and regulatory personnel involved in the development and commercialization of medical devices, ensuring their products meet the highest standards of quality and safety.