|
|
|
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. | |
|
|
|
By Venkatesan Muthukrishnan, Johnson & Johnson | Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study. | |
|
|
|
By Benjamin Austin, IMed Consultancy | The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies qualify as medical devices based on their intended purpose and functional impact. | |
|
|
|
|
|
|
|
|
|
|
| Connect With Med Device Online: |
|
|
|
