
CE certification for medical devices – scope and strategy
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?
2AM Health has 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 www.passago.org to simplify the regulatory information access and document preparation process. We are glad to share this expertise with the Lithuanian ecosystem.
During this webinar, you 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.
PROGRAM:
10:30 – 11:15 Navigating MDR – CE certification process and interpretation of regulatory requirements
11:15 – 11:30 Certification – simplified: what can you do by yourself and where to invest in expert support
11:30 – 12:00 Q&A
At the end of the webinar all the participants will get a surprise!
Registration: https://www.linkedin.com/events/cecertificationformedicaldevice6998938323675156480/

