On the 9th of December 2022 2AM Health kicks-off “STARTUP - EMPOWERED” webinar series with a CE certification webinar, where the expert team will discuss the certification process for medical devices and digital health products.
CE certification process and requirements are complex and resource-consuming. Often, it is hard to know where to start from and how to effectively navigate the standards and required documentation, while staying warry of time and money limitations. How much can a company prepare independently, and which tasks should be outsourced?
At 2AM Health we have been supporting medical device and digital health companies in their certification process, in all class categories. In addition, our team has developed a digital tool passago. to simplify the regulatory information access and document preparation process. During the webinar we will be sharing this expertise with the Lithuanian ecosystem and answering all the burning questions. The attendees will receive practical guidance on where to start, what to prepare, how long it takes and how much it costs, depending on if you do it yourself or get an expert to help you. PROGRAM: 09:30 - 10:15 CET Navigating MDR - CE certification process and interpretation of regulatory requirements (in English) 10:15 - 10:30 CET Certification - simplified: what can you do by yourself and where to invest in expert support (in Lithuanian) 10:30 - 11:00 CET Q&A At the end of the webinar all the participants will get a surprise!
Registration to the webinar: https://bit.ly/3iurEXN
More about passago. knowledge hub: Knowledge hub passago.
The next “STARTUP-EMPOWERED” webinar topic will be announced end of December 2022. The webinar will be held in January 2023.