Date: 23 March 2023
Time: 17:00 - 18:00 PM CEST | 11:00 - 12:00 AM EST | 8:00 - 9:00 AM PST
Location: Virtual
Language: English
Introduction
How much is enough? Keeping patients a priority while satisfying EU and US regulators.
Stakeholders are gaining experience and challenged with EU-IVDR. Leveraging the more stable US FDA regulatory process and documentation has become a practical approach to satisfying EU and US regulators concurrently.
IVD companies are reevaluating their market entry priorities and considering going to the US market prior to Europe. This is partially a result of the challenges and long lead times to meet the IVDR.
Gert Bos will interview three IVD specialists from the Qserve team in this webinar. In a question-and-answer format, we will share our knowledge from practical experience from writing technical files and responding to questions from Notified Bodies, writing US pre-submissions, 510(k)s, IDEs, and the FDA interactions associated with them.
We are going to look at the past when Qserve started 25 years ago and guide you through the present so you can succeed in this challenging time and finally glimpse the future.
The free webinar closes with a Q&A for which you can send in questions prior to the webinar. Use the registration form to send in questions, use the Questions Tab during the Webinar, or mail them beforehand to marketing@qservegroup.com.
Hosted by Gert Bos and the IVD professionals: