Regulatory Information

This page contains 5 sections:

1. Company certificates: Includes valid Notified Body assessment certificates as well as Free Sales certificate.
2. Declaration of conformity: The written statement and the declaration drawn up by Atos to demonstrate the fulfillment of applicable requirements.
3. Technical information: Technical data and material data sheets contain product specific information such as reference numbers, classification, and other vital data.
4. Product statements: This section contains generic statements, such as MRI safety, for the Atos Medical product range.
5. Complaint report: This is the template that shall be used to ensure that as much information as possible is recorded and to simplify the reporting of complaints on Atos Medical products.

1. Company Certificates

Atos always prioritizes product safety and quality from the early stages of designing a new product, through production, and until the end of its life cycle. We maintain a certified Quality Management System based on ISO 13485 in compliance with regulatory requirements everywhere we operate.

We analyze, evaluate, and control the product risks related to our products, and maintain a post market surveillance process where all product safety and quality concerns are systematically documented to ensure timely reporting to authorities and give important input for improvement of the product quality.

The Certificates document bundle contains the following certificates:

2. Declaration of Conformity

A declaration of conformity is the written statement and the declaration drawn up by Atos to demonstrate the fulfilment of applicable requirements relating to a product bearing the CE marking we have manufactured. The declaration is in respect of all acts applicable to the product containing all information required for the identification of harmonized legislation to which the declaration relates.

The Declaration of conformity document bundle contains technical information for the following products:

Declaration of conformity – Other products – iSKiA products

3. Technical Information

Technical data and material data sheets contain product specific information such as reference numbers, classification and other vital data.

New documents are issued when changes are made to the products.

Note! Technical Information is maintained throughout the intended lifetime of a device even if the device has been discontinued.

Provox ® Life products

Provox ®

The Provox® document bundle contains technical information for the following products:

Provox® FreeHands

Provox® FreeHands

The Provox® FreeHands document bundle contains technical information for the following products:

Provox® HME accessories

The Provox® HME accessories document bundle contains technical information for the following products:

Provox® HME cassettes

The Provox® HME cassettes document bundle contains technical information for the following products:

Provox® Laryngectomy products

The Provox® laryngectomy document bundle contains technical information for the following products:

Provox ® voice rehabilitation

The Provox® voice rehabilitation document bundle contains technical information for the following products:

Provox ® Life products  

The Provox® Life document bundle contains technical information for the following products:

Tracheostomy

The tracheostomy document bundle contains technical information for the following products:

FreeVent

The Freevent document bundle contains technical information for the following products:

Other

Therabite

The Therabite document bundle contains technical information for the following products:

TympoVent

The TympoVent document bundle contains technical information for the following products:

4. Product Statements

MRI safety and other information statements for the Atos Medical product range.

5. Complaint Report

Use this for to report complaints regarding the performance of Atos Medical devices.