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Technical Documentation

for Medical Products

Genre: Diagnostics / Therapeutics
Length: 38 minutes
Keywords: Approval of Medical Products, EMEA, FDA, ISO 13485, ISO 9001, Quality Management, CE-Label

Technical Documentation for Medical Products

Technical Documentations typify total documentation data for medical products and are obligatory for quality assignment and approval. Therefore every medical product has to possess such a documentation compilation. Here completeness and correctness of technical documentations is important because this file is subject of investigations of authorities responsible for quality assignment (CE label) or approval.

Prospective project managers dealing with technical documentations, especially quality managers, have to consider presence and completeness of this management file. Here responsible person often acts as contact person for audits of local or global authorities.

This seminar deals with assembly of technical documentations and gives advices for compliant documentation structures required within quality management systems.
Furthermore generation of stability data for identification of expiry dates is illustrated.

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