During these unprecedented times, medical device companies needed to be quick on their feet. These past few months, manufacturers were challenged by emergency authorization orders from FDA, an industry shortage of PPE, and limited testing capabilities. This session will cover the quick collaborations between regulators, laboratories, and medical device sponsors to meet the need. We will also discuss the learning that developed during this crisis and how you can apply this learning going forward to make our industry stronger.
Key points in this webinar:
- What you need during the pandemic to get vital devices in the hands of the users?
- What considerations is FDA asking for?
- How did we show these devices were safe to the users—not just effective?
- How can we apply these learnings post pandemic?