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Aleksandar S. | Elance
 
176985602337900
Last Sign-in: Feb 19, 2016

Aleksandar S.

'Quality', 'CE', 'FDA', 'ISO 13485', 'Documents'
   Serbia
  |   Nis, Central Serbia
  |  4:23 am Local Time

Overview

Minimum Hourly Rate $30

Quality Management, Risk Management, Process Control, System Improving, Quality Assurance process of production medical devices and laboratory devices in accordance with standards ISO 9001, ISO 13485, FDA 21 CFR 820, ISO 14971 and MDD 93/42/EEC,

Preparation of a Technical Files (CE marking - Technical file requirements, Review of the Technical Files, Documenting the Technical Files),

Audit of process according the requirements of ISO 9001, ISO 13485, ISO 14971 and MDD 93/42/EEC.

Read More »
Oct 28, 2015|Content Management|Private|Completed
|
5.0
Sep 16, 2015|Other - Administrative Support|Private|Completed
|
5.0

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Portfolio

Skills (10)

Tested
ISO 9001 - ISO 13485 - ISO 14971 - FDA 21 CFR 820
CE marking - Technical File requirements
Preparing QMS Documentation of Processes
Review of the TF for CE Mark - Auditing
Quality Auditing of Production Facilities
MDD 93/42/EEC - IEC 60601-1 - IEC 60601-1-2
EN 62304 Medical device software-life-cycle processes
EN 62366 Usability Engineering for Medical Devices
Quality Management System ISO 9001
Medical Device Management System ISO 13485

Education

Faculty of Electronic Engineering, Serbia
MSc Electronic Engineer
-
Overview  |  Job History  |  Portfolio  |  Resume/C.V.

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aleksandarsiskovic
Type
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Member Since
March 2015
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Aleksandar S. | Elance

Aleksandar S.