businessHosted by Regulatory Affairs Professionals Society (RAPS)
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This virtual workshop provides practical guidance on obtaining Notified Body Opinions for integral drug-device combination products under Article 117 of the EU MDR. It covers GSPR compliance, technical documentation, risk management, interactions with Notified Bodies and competent authorities, common deficiencies, and submission strategies.
Date
Time
09:00 AMPlatform
Digital Hub
Global
Hosted By
Regulatory Affairs Professionals Society (RAPS)
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