FDA registration

FDA registration

US market is probably the most desired goal for a Medical Device manufacturer.

Precise knowledge of FDA world can transform approval process in a quick and convenient way.

We offer such services:

1.  US market: FDA Registration, Establishment Registration and Listing
We manage all the process of registration Establishment and products on the US market, from Establishment Registration and Listing to 510(k)

2.  US market: Design Control

We assist companies in understanding and implementation of the Design Control according 21CFR820, necessary for the access to US market

News and events

Clause will participate in Arabian Health
24.01.2017
Clause will participate in Arabian Health

News
21.09.2016
CLAUSE Ltd, the leading contract research organization in Europe is pleased to announce the opening of a new branch office in Praha, Czech Republic.

Сontacts

We will be glad to cooperate

Feel free to contact us for any questions using any convinient way for you!

Tel +38 095 596 0666; +38 057 751 66 99

e-mail: office@clause-audit.com

Address: 20V, Kul'tury str., off.19

Kharkiv ,61058,Ukraine

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