notified body

Many people had to transition to a remote work environment amidst the COVID-19 pandemic, with Notified Bodies being no exception. This meant that medical device companies had to be audited virtually, which left many unsure as to how successful a...

Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week...

The EU Commission committed to provide information on the availability and the capacity of the notified bodies to conduct conformity assessments in the Joint European Roadmap towards lifting COVID-19 containment measures released on April 15, 2020.1 The EU commission conducted...

If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an...