Question: Per regulation EU 2017/745 technical documentation for a medical device in the EU must contain which of the following: a.Sterilization Validation data b.Evidence that the

Per regulation EU 2017/745 technical documentation for a medical device in the EU must contain which of the following:

a.Sterilization Validation data

b.Evidence that the device meet the GSPR

c.Design verification and validation studies

d.Risk Management file according to EN ISO 14971

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