Who is required to submit a 510(k)?

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)

Substantial Equivalence in 510(k)

Read and understand about Substantial Equivalence to protect your application.

7.6.2022

510k Process Guide

510k Process Guide

Are you launching your device in the USA? Find out more about 510(k) requirements.

1.6.2022

Basics of EU Authorised Representative

Basics of EU Authorised Representative

Let's find out more information about EU Authorised Representative!

20.5.2022

IVDR Celebration Week - Opening Ceremony

IVDR Celebration Week - Opening Ceremony

Details of the Opening Ceremony!

21.4.2022

IVDR Celebration Week Session 1

IVDR Celebration Week Session 1

Details of Session 1 - Overview of IVDR

21.4.2022

IVDR Celebration Week Session 2

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

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

IVDR Celebration Week Session 4

Details on Session 4 - IVD Medical Device - the need for UDI and Barcodes

21.4.2022

VIEW MORE ITEMS