Jon Bergsteinsson's guest appearances

Jon Bergsteinsson

Medical Device made Easy Podcast

Project Medtech Podcast

Mastering Medical Device

Scott Carson

Scott Anderson

David Nelson

Jason Lim

Bob Beck

Erik Vollebregt

Tania Aprigliano

Michelle Lott

Ed Drower

Justin Bushko

Natasha Bankowski

Helene Quie

Mitch Robbins

Sharon Ayd

Karandeep Badwal

OwlTail

Jon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.Links from this episode:Jon Bergsteinsson LinkedInSmart-TrialMastering Medical Device:WebsitePat Kothe LinkedIn

<p>Jon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.<br/><br/>Links from this episode:</p><ul><li><a href="https://www.linkedin.com/in/joningib/" rel="nofollow" target="_blank">Jon Bergsteinsson LinkedIn</a></li><li><a href="https://www.smart-trial.com" rel="nofollow" target="_blank">Smart-Trial</a></li></ul><p><br/>Mastering Medical Device:</p><ul><li><a href="https://www.masteringmedicaldevice.com/" rel="nofollow" target="_blank">Website</a></li><li><a href="http://www.linkedin.com/in/patrick-kothe" rel="nofollow" target="_blank">Pat Kothe LinkedIn</a></li></ul>

Clincal Study, Case Series, Registry, Survey - What They Should All Have in Common with Jon Bergsteinsson

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… Links  Jon’s LinkedIn Profile: https://www.linkedin.com/in/joningib/ Smart-trial: https://www.smart-trial.com/The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] first appeared on Medical Device made Easy Podcast.The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

<p>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. </p><ul><li>History of Clinical Data Collection </li><li>Difference between Big and small companies </li><li>Use of CRO for collecting data </li><li>Difference on Clinical Investigation and PMCF data collection </li></ul><p>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.</p><h2>Who is Jon Bergsteinsson? </h2><p>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. </p><h2>Who is Monir El Azzouzi? </h2><p>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 <a href="http://EasyMedicalDevice.com" rel="nofollow" target="_blank">EasyMedicalDevice.com</a> 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… </p><h2>Links  </h2><ul><li>Jon’s LinkedIn Profile: <a href="https://www.linkedin.com/in/joningib/" rel="nofollow" target="_blank">https://www.linkedin.com/in/joningib/</a> </li><li>Smart-trial: <a href="https://www.smart-trial.com/" rel="nofollow" target="_blank">https://www.smart-trial.com/</a></li></ul><p>The post <a href="https://podcast.easymedicaldevice.com/146/" rel="nofollow" target="_blank">How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.</p><p>The post <a href="https://podcast.easymedicaldevice.com/146/" rel="nofollow" target="_blank">How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a></p>

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

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. –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. About SMART-TRIAL 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. 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 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… Links from the Video Jon’s LinkedIn Profile: https://www.linkedin.com/in/joningib/ Smart-trial presentation: https://www.youtube.com/watch?v=lJTGnuAJ2Ng Link to download the Medical Device Sample Size Cookbook: https://info.smart-trial.co/ebook/medical-device-sample-size-cookbook Link to watch the webinar on how to estimate sample size for medical device studies: https://info.smart-trial.co/webinar/how-to-estimate-sample-size-for-medical-device-studies Other white papers and webinars for MedTech professionals: https://info.smart-trial.co/resource/content-curated-for-the-medtech-industryThe post How to calculate your sample size with Jon Bergsteinsson first appeared on Medical Device made Easy Podcast.The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

<p>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. –</p><h2>Who is Jon Bergsteinsson? </h2><p>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. </p><h2>About SMART-TRIAL </h2><p>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. </p><h2>Who is Monir El Azzouzi? </h2><p>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 <a href="http://EasyMedicalDevice.com" rel="nofollow" target="_blank">EasyMedicalDevice.com</a> 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… </p><h2>Links from the Video </h2><ul><li>Jon’s LinkedIn Profile: <a href="https://www.linkedin.com/in/joningib/" rel="nofollow" target="_blank">https://www.linkedin.com/in/joningib/</a> </li><li>Smart-trial presentation: <a href="https://www.youtube.com/watch?v=lJTGnuAJ2Ng" rel="nofollow" target="_blank">https://www.youtube.com/watch?v=lJTGnuAJ2Ng</a> </li><li>Link to download the Medical Device Sample Size Cookbook: <a href="https://info.smart-trial.co/ebook/medical-device-sample-size-cookbook" rel="nofollow" target="_blank">https://info.smart-trial.co/ebook/medical-device-sample-size-cookbook</a> </li><li>Link to watch the webinar on how to estimate sample size for medical device studies: <a href="https://info.smart-trial.co/webinar/how-to-estimate-sample-size-for-medical-device-studies" rel="nofollow" target="_blank">https://info.smart-trial.co/webinar/how-to-estimate-sample-size-for-medical-device-studies</a> </li><li>Other white papers and webinars for MedTech professionals: <a href="https://info.smart-trial.co/resource/content-curated-for-the-medtech-industry" rel="nofollow" target="_blank">https://info.smart-trial.co/resource/content-curated-for-the-medtech-industry</a></li></ul><p>The post <a href="https://podcast.easymedicaldevice.com/73/" rel="nofollow" target="_blank">How to calculate your sample size with Jon Bergsteinsson</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.</p><p>The post <a href="https://podcast.easymedicaldevice.com/73/" rel="nofollow" target="_blank">How to calculate your sample size with Jon Bergsteinsson</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a></p>

How to calculate your sample size with Jon Bergsteinsson