How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]

Medical Device made Easy Podcast

Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

2+ y ago

MP3•Episode home

Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data.

History of Clinical Data Collection
Difference between Big and small companies
Use of CRO for collecting data
Difference on Clinical Investigation and PMCF data collection

So if you still think that we should collect data by hiring people that are going to healthcare facilities and transfer data on paper or excel sheets then you should listen to this episode. The world is changing.

Who is Jon Bergsteinsson?

Jon co-founded the company behind SMART-TRIAL and served as the CTO until 2017, where he paved the way for the platform’s quality standard, data security, and compliance. With a background in Biomedical Engineering and 10 years of experience in clinical research and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data management with the MedTech industry.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…