This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.
"Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO"