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When you are starting a study like a Clinical Trial or Clinical Investigation or PMCF, you arrive at a point where you need to define how many people need to be included. This is the sample size. In this episode, we will help you to calculate your sample size. My guest is Jon Bergsteinsson VP at Smart-trial. He will present to us the way a sample size needs to be considered so your project is successful. To help you with sample sizing, Jon is also offering an eBook so you can get all the information needed to perform that by yourself. So don’t forget to download it. –

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.

SMART-TRIAL offers a do-it-yourself Electronic Data Capture for clinical investigations and PMCF activities, including registries and surveys. Built to empower MedTech clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company 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, Podcast, Online courses…

• Jon’s LinkedIn Profile: https://www.linkedin.com/in/joningib/

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