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Regulatory Affairs

for Medical Products

Genre: Diagnostics / Therapeutics
Length: 32 minutes
Keywords: Medical Products, IVDs, Classification by Risk Potential, CE Labelling, Approval

Regulatory Affairs for Medical Products

Every company has to face increasing demands of regulatory authorities. In case of diagnostic and therapeutic products in particular risk potential has to be considered.
Here European and US agencies published directives to classify own medical products which also directs towards specific approval procedures.

Prospective project managers dealing with Regulatory Affairs have to realize: compliance in documented quality and safety regulations decides about successfull approval in corresponding country.

This seminar delivers insider information on setting up quality management systems compliant to ISO 9001 with several templates for own establishment. Furthermore classification of medical products due to international guidelines and following approval process is illustrated.

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