Medical Device Training
July 2 @ 9:30 am - 1:00 pm
The training will look to answer the following questions:
– How to know if your technology is a Medical Device / IVD / SaMD?
– What is the Legislation you need to meet if it is?
– How do you work out the product Risk Class?
– What Design Control activities are needed to ensure Regulatory Compliance?
– What is the typical contents of a Technical File
– What are the requirements of ISO 13485?
– What can you do right now to ensure Regulatory Compliance?