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.
• 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?
ABOUT NELSON LABS:
Nelson Labs, a Sotera Health company, is the industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
With the addition of Nelson Labs Europe, we are the leading global extractables and leachables lab testing platform. We have over 700 scientists, technicians, and service specialists who diligently performing more than 700 rigorous tests in 13 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.