Service
EU Technical Documentation Preparation
Preparation and/or review of the Technical Documentation or any specific section that forms part of the Technical Documentation.
Senior Regulatory Affairs Manager
Alira Health
Barcelona, Spain
14:45 - 15:00
Speaker: Sara Ramió Pujol, Regulatory Expert, Alira Health
Service
EU Technical Documentation Preparation
Preparation and/or review of the Technical Documentation or any specific section that forms part of the Technical Documentation.
Service
EU Notified Body (NB) and National Authorities
Support and accompaniment during the evaluation and interactions with regulatory authorities
Service
Internal audit capacities as per MDR/IVDR, and per ISO13485:2016, QMSR, and MDSAP
Service
FDA Submissions including Documentation Preparation
Advise, prepare and manage FDA package submission
Service
Quality Management System Gap Analysis
Quality Management System analysis and recommendation on how to solve the gaps
Service
Quality Management System Implementation
Materials and Support for the implementation of a Quality Management System