Arazy Group – Medical Device Consultants
Arazy Group – Product Compliance – Essential Requirements – IEC 60601-1
Arazy Group – Product Compliance – Essential Requirements – IEC 60601-1-2
Arazy Group – Product Compliance – Essential Requirements – IEC 60601-1-4
Arazy Group – Latest news on Medical Devices Regulation

Arazy Group – Relevant Articles about Medical Devices Regulation
If you want to know more about regulatory issues of Medical Devices, click here.
 
 
Arazy Group Home » Product Compliance
 
 
How to Demonstrate Product Compliance
 
For your product to appeal to potential markets, it has to be shown to be safe and effective. While clinical trials, and other types of testing, are aimed at demonstrating the effectiveness of the product, there is a battery of specific tests your product has to undergo in order to assure its safety. These tests should be performed by certified laboratories to prove that the device is safe both for the user and the patient.

In essence, the safety requirements, despite slight technical variations, are valid in all major markets - Europe, the USA and most other countries. The battery of tests applicable for your product will be tailored according to its nature.

In addition, other important issue to assure the safety of your products is the implementation of an adequate labeling process. Arazy Group offers you a review of the labeling executed by our professionals.

Most of these services can be provided by Arazy Group. Selecting and clicking on the proper yellow button you can obtain more information on them.

If you want to contract any of these services, please click on “Tell us what you need”. Fill-in the form and we will contact you. Thank you!
 
Arazy Group – Product Compliance – Essential Requirements – ISO10993
Arazy Group – Product Compliance – Essential Requirements – EN550, EN552, and EN554
Arazy Group – Product Compliance – Essential Requirements - EN980
Arazy Group – Medical Device Regulation - What is CE mark and FDA approval? – FAQs
Arazy Group – Medical Device Regulation – Online Products
 
 
Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants
2005 Copyright Arazy Group. All rights reserved. | Private Policy