Medical Device made Easy Podcast
Technology
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices.
You may have made also this mistake and it would be better to know that before your Notified Body rejects your application.
You will understand how to solve that and get some advice from Cesare.
Who is Cesare Magri?Cesare has a mixed Background: Physics and Neuroscience, Ph.D. in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.
LinksThe post Your Software/IVD clinical report is completely WRONG! appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Summative Evaluation – Common mistakes
Are you more Corrections or Corrective Actions or Preventive Actions?
How to select and evaluate your Contract Manufacturer?
Quality Field Service for Medical Devices
Medical Device NewsMAY 2024 Regulatory Update
Why and how to build a Quality Culture?
What is the impact of AI Act on Medical Devices?
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device News April 2024 Regulatory Update
How to benefit from Surveys to build Clinical Evidence?
How to do Postmarketing Surveillance the right way?
Learn more about FDA QMSR alignment with ISO 13485
Medical Device News March 2024 Regulatory Update
New EU Proposal – EUDAMED, IVDR & Shortage
Will EtO gaz become a Medical Device?
How to get your interview prepared?
Medical Device News february 2024 Regulatory Update
Why you should use Pre-Submission or Q-Sub with FDA?
You are not the Physical Manufacturer, can you be MDR certified?
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
Create your
podcast in
minutes
It is Free
Insight Story: Tech Trends Unpacked
Zero-Shot
Fast Forward by Tomorrow Unlocked: Tech past, tech future
The Unbelivable Truth - Series 1 - 26 including specials and pilot
Lex Fridman Podcast