Who is required to submit a 510(k)?
The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission
9.6.2022
Who is required to submit a 510(k)?
The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission
9.6.2022
Substantial Equivalence in 510(k)
Read and understand about Substantial Equivalence to protect your application.
7.6.2022
Are you launching your device in the USA? Find out more about 510(k) requirements.
1.6.2022
Basics of EU Authorised Representative
Let's find out more information about EU Authorised Representative!
20.5.2022
IVDR Celebration Week Session 2
Details on Session 2 - IVDR and the Clinical Requirements for IVD Manufacturers in Europe
21.4.2022
IVDR Celebration Week Session 3
Details on Session 3 - IVD Medical Device - Understanding SaMD and Cyber Security Requirements
21.4.2022
IVDR Celebration Week Session 4
Details on Session 4 - IVD Medical Device - the need for UDI and Barcodes
21.4.2022
