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By Srividya Narayanan, MSc, CQSP, Asahi Intecc and Apekshit Mhatre, Northeastern University | Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards. | |
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By Jim Kasic, Boulder iQ | The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions. | |
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By Andrew Walsh, Thomas Altmann, Joshua Anthes, Ralph Basile, et al. | Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach. | |
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| Regulatory Requirements For Medical Device Manufacturers | Article | By Patrick Lemay, Tulip | Ensure your medical device labeling meets regulatory standards and supports product traceability. Explore key labeling requirements to help protect your business and safeguard patient health. |
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| AI: The New Partner In Medical Device Development | Article | Battelle | Involving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals. |
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