Software CE Marking

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Information about Software CE Marking
Health & Medicine

Published on June 28, 2014

Author: so24so

Source: slideshare.net

Description

Software CE Marking

CE Marking of Medical Software Step 01 - Identify device and versions. Step 02 - Appoint technical expert with previous experience. Step 03 - Identify Class and route of CE Marking Step 04 - Implement ISO 13485 & ISO 62304 Step 05 - Demonstrate compliance with MDD Directive Step 06 - Develop User Instruction /manuals /Labels. Step 07 - Software verification and test cases Step 08 - Preparation of Technical File Step 09 - Appoint NB for Certifying your medical software. Step 10 - Submit Technical File to Notified Body Step 11 - Correct / Update TF as per NB reviewer Comments. Step 12 - Facility Audit by Notified Body auditor Step 13 - Affix CE Mark on your Medical Software

Why to appoint I 3 Consulting ? 1 Previous experiences 2 In-house consultants and Auditors 3 Undertake turnkey projects 4 Cloud documentation and storage 5 Online and Onsite consultation in Europe, USA, Middle East & India. 6 1238 Certified clients across the globe. 7 Phased Payments 8 Office in USA, India and Muscat. 9 16 No. Consultants, 4 No. Team Leaders and 2 No. Project Heads 10 Certified Lead auditors for ISO 13485 & ISO 62304 More Information visit our informative website www.i3cglobal.com

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