Prepare your transition from Class I to Class Ir
The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode, Tautvydas from Test Labs will explain to us what is expected from Medical Device Manufacturers. What they should prepare for being compliant with the new regulation?
Who is Tautvydas Karitonas?
Tautvydas is focused on accelerating access to the market for medical devices. He has almost a decade of experience developing state-of-the-art products for healthcare, which are now used in hospitals worldwide. Tautvydas provides expertise in product development, validation, and problem-solving.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- LinkedIn profile Tautvydas: https://www.linkedin.com/in/tautvydaskaritonas/
- Test Labs webpage: www.testlabsuk.com
- MDCG 2020-2 – Class I transition: https://health.ec.europa.eu/document/download/e87d08dc-87ab-49d9-8ffa-5552fa978d14_en
- Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/