CE Mark process for a medical device
Many of my interactions with clients begin when they contact me wishing to gain CE Mark approval for their device to allow them to sell the product into the European Economic Area (EEA). We generally begin with high-level training to support their understanding and...
Vigilance and Medical Device Reporting
In order to ensure that medical devices distributed to the market remain safe and perform as intended, adverse events or incidents are reported to the appropriate Regulatory Authorities. In Europe, this system is known as the vigilance system. In the U.S., this...