Webinars sobre productos sanitarios

Webinars sobre productos sanitarios en directo y bajo demanda

MDR Conformity Assessment Routes in the AIMD space
Extension to the MDR transition timelines
Understanding Periodic Safety Update Reports and submitting to BSI
Preparing a Summary of Safety and Clinical Performance (SSCP)
Preparing a Post Market Clinical Follow Up Plan & Evaluation Report
Preparing a Clinical Evaluation Report (Part 2)
Preparing a Clinical Evaluation Report (Part 1)
Preparing a Clinical Evaluation Plan
Article 54 Understanding the Clinical Evaluation Consultation Process
Post market clinical follow up under MDR
Clinical evaluation for medical software & AI devices
Claiming equivalence under the MDR – regulatory considerations
Understanding Article 61 (10) – When Clinical Data is not deemed appropriate
Well-established technologies - defining the criteria from MDCG 2020-6
AIMDD to MDR transition - what you need to know
Active Implantable Medical Devices under the EU MDR at MedTech Summit 2021
Personalised Medical Devices - what you need to know
The Periodic Safety Update Report (PSUR) & Vigilance under the MDR
MDR Rule 14 Devices – conformity assessment process and documentation requirements for submissions
MDR lessons learnt
Clinical evaluation under the MDR – the requirements?
BSI view on Article 117 and drug-device combinations
MDR - What we currently know
MDR Conformity Assessment Routes