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IAF Brochure: (Download brochure in PDF format (2.2 Meg) View brochure as single web page.


The IAF Initiative for Accredited Certification to ISO 13485 -  Medical Devices

Brochure Content

Introduction

ISO 13485 accredited certification within a national regulatory framework

Relationship to guidance from the Global Harmonization Task Force (GHTF)
 
How ISO 13485 certification relates to product certification

The IAF Multilateral Recognition Arrangement (MLA)

Structure of the MLA

IAF MLA Mark
 
Key Features of the Initiative

Reports associated with the IAF Initiative

Using Accredited ISO 13485 Certification in Practice 

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ISO 13485 Medical Devices IAF Br Contents 1

ISO 13485 Medical Devices IAF Br Contents 2 


Brochure Navigation:

IAF Br: IAF Reports associated with ISO 13485 (medical devices)IAF Br: IAF Reports associated with ISO 13485 (medical devices) Brochure Contents
Introduction to Accreditiation / Certification ISO 13485 Medical Devices 

Introduction

ISO 13485: Quality accredited in a national regulatory framework 

SO 13485 accredited certification within a national regulatory framework 

 ISO 13485 Medical Devices Br: Global Harmonization Task Force Relationship to guidance from the Global Harmonization Task Force (GHTF) 
IAF Br: How ISO 13485 certification relates to product certification  How ISO 13485 certification relates to product certification 
The IAF Multilateral Recognition Arrangement (MLA)
Structure of the MLA 
IAF Br: Risk Classification of Medical Devices to QMS requirements 

IAF MLA Mark
Key Features of the Initiative 

 IAF Br: IAF Reports associated with ISO 13485 (medical devices) Reports associated with the IAF Initiative 
Using Accredited ISO 13485 Certification in Practice 
 

 

 

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