Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.
In this recorded webinar, Ronald Boumans, a Senior Regulatory Consultant at Emergo’s office in The Hague, examines the potential impact of a no-deal Brexit and how manufacturers, patients, and healthcare providers can prepare.
A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.
The US is the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission.