Three experts will share with you the requirements to MDR and IVDR implementation and the changes to the former Directives. This training offers at the same time individual consulting sessions as needed. The training is planned for 2 days, but to make it cost effective for your company you may only book individual days as needed.
Representatives from Regulatory Affairs, Clinical Affairs or Quality Assurance. CEO´s, Managers or Specialist of smaller companies from international locations, but also mid-size to bigger companies may benefit from this event.
Beside others we will cover with you Changes to MDR/ IVDR, Notified Body selection, working with Contract Manufacturers, Document Control System, Qualified Person, Economic Operators and responsibilities, Software Validation, Labeling and Translations, Clinical Evaluation and Clinical Evidence, Data Protection….
The three experts together have more than 80 years of experience in Regulatory Compliance. Their goal is that all participants will be enabled to create successful strategies for a timely implementation of the new regulations.
DOM PEDRO LISBOA, Av. Eng. Duarte Pacheco 24, 1070-110 Lisboa, Portugal
+49 1 60 92 37 74 84