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The Ministerial Decision (MD) 1348/2004 concerns companies who market and distribute medical devices The MD describes principles and guidelines of distribution best practice for such products. The verification of these principles implementation is contacted by independent certification bodies which undertake to certify the proper respect for those required by the decision.
PRIORITY has the necessary expertise to develop for the customer a system based on the MD requirements.
At first, the diagnostic study will identify the gaps of the company operation with the requirements of the MD
Then an action plan will be set that will define person in charge and implementation date for each action. Also, the written procedures of the system are recorded and confirmed.
After completing the above, PRIORITY will train the personnel on new procedures. Priority will conduct internal audit to ensure the proper maintenance of the system.
During the certification audits by the certification body, PRIORITY provides customer support and undertakes to complete non-compliances that may occur.
In addition, PRIORITY may support the customer after certification by conducting internal audits and providing consulting services.
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