The Medical Devices Introductory Course 2020
Post Market Surveillance
2017/745 Annex III “TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE”
•
“The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex” Provides further definition of the documentation needed to demonstrate conformity with prior Articles and the specific inputs, outputs and methodologies for the PMS
The Organisation for Professionals in Regulatory Affairs
Post Market Surveillance
The Organisation for Professionals in Regulatory Affairs
Made with FlippingBook - Online Brochure Maker