Ronald Boumans's guest appearances

Ronald Boumans

Medical Device made Easy Podcast

Jason Lim

Erik Vollebregt

Tania Aprigliano

Michelle Lott

Ed Drower

Justin Bushko

Natasha Bankowski

Helene Quie

Mitch Robbins

Sharon Ayd

Karandeep Badwal

Samantha Alsbury

Sean Hamilton

Angelina Hakim

Richard Young

OwlTail

Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue. PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it.Ronald Boumans will help us understand what should we do to become the best PRRC ever. Who is Ronald Boumans? Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&amp;D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation, and consulting), so he can approach most challenges from multiple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance. Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&amp;D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life. This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Boumans Regulatory Consulting website: https://boumansconsulting.com/ Ronald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/ Team-PRRC Annual Meeting: https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public Team-PRRC website: https://www.team-prrc.eu/page/1111392-presentation PRRC Video LinkedIn Live: https://www.youtube.com/watch?v=RHRI9UjEdjsThe post How to become the best PRRC ever? [Ronald Boumans] first appeared on Medical Device made Easy Podcast.The post How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

<p>Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue. </p><p>PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it.</p><p>Ronald Boumans will help us understand what should we do to become the best PRRC ever. </p><h2>Who is Ronald Boumans? </h2><p>Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&amp;D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation, and consulting), so he can approach most challenges from multiple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance. Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&amp;D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life. This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company. </p><h2>Who is Monir El Azzouzi? </h2><p>Monir El Azzouzi is a Medical Device Expert specializing 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. </p><h2>Links from the Video </h2><ul><li>Boumans Regulatory Consulting website: <a href="https://boumansconsulting.com/" rel="noreferrer noopener nofollow" target="_blank">https://boumansconsulting.com/ </a></li><li>Ronald Boumans LinkedIn: <a href="https://www.linkedin.com/in/ronald-boumans-34790055/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/ronald-boumans-34790055/ </a></li><li>Team-PRRC Annual Meeting: <a href="https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public" rel="noreferrer noopener nofollow" target="_blank">https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public </a></li><li>Team-PRRC website: <a href="https://www.team-prrc.eu/page/1111392-presentation" rel="noreferrer noopener nofollow" target="_blank">https://www.team-prrc.eu/page/1111392-presentation </a></li><li>PRRC Video LinkedIn Live: <a href="https://www.youtube.com/watch?v=RHRI9UjEdjs" rel="noreferrer noopener nofollow" target="_blank">https://www.youtube.com/watch?v=RHRI9UjEdjs</a></li></ul><p>The post <a href="https://podcast.easymedicaldevice.com/198/" rel="nofollow" target="_blank">How to become the best PRRC ever? [Ronald Boumans]</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/198/" rel="nofollow" target="_blank">How to become the best PRRC ever? [Ronald Boumans]</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 become the best PRRC ever? [Ronald Boumans]

We started to talk a lot about Brexit, but in the meantime for the Medical Device Industry, Swixit is starting to happen. This is for Switzerland Exist from the European Union. But here we are not talking about the same exit as for the UK. Here we are talking only about the Medical Device industry. Learn more in this episode of the Medical Device made Easy Podcast with Ronald Boumans from Emergo. He will explain to us what is happening to the Swiss market and what can be done to be ready. Who is Ronald Boumans? Ronald Boumans started his career as an industrial designer working in R&amp;D designing smart packaging concepts. He has also had his own company importing medical devices from the far east into The Netherlands. After that failed he worked for an organization researching the relation between quality of life and the use of medical devices. This brought him to a certification organization (TNO). After that, he worked as a senior Inspector for medical technology for the Dutch Competent Authority. In 2013 he started working for Emergo as a senior consultant where he is now specializing in the European legislation and the political developments (e.g. Switzerland, Brexit). He is also a board member of the European Association of Authorized Representatives (EAAR) which he represents at the European Commission in several Eudamed and UDI working groups.  LinksRonald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/Emergo website: https://www.emergobyul.com/Is Switzerland becoming a Third-Country: https://www.emergobyul.com/blog/2020/01/mdr-watch-switzerland-becoming-third-country Swiss Medtech Letter:  https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf The post Swixit or not Swixit? this is the question with Ronald Boumans first appeared on Medical Device made Easy Podcast.The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

<p>We started to talk a lot about Brexit, but in the meantime for the Medical Device Industry, Swixit is starting to happen. </p><p>This is for Switzerland Exist from the European Union. But here we are not talking about the same exit as for the UK. Here we are talking only about the Medical Device industry. </p><p>Learn more in this episode of the Medical Device made Easy Podcast with Ronald Boumans from Emergo. He will explain to us what is happening to the Swiss market and what can be done to be ready. </p><h2>Who is Ronald Boumans? </h2><p>Ronald Boumans started his career as an industrial designer working in R&amp;D designing smart packaging concepts. He has also had his own company importing medical devices from the far east into The Netherlands. </p><p>After that failed he worked for an organization researching the relation between quality of life and the use of medical devices. This brought him to a certification organization (TNO). </p><p>After that, he worked as a senior Inspector for medical technology for the Dutch Competent Authority. In 2013 he started working for Emergo as a senior consultant where he is now specializing in the European legislation and the political developments (e.g. Switzerland, Brexit). </p><p>He is also a board member of the European Association of Authorized Representatives (EAAR) which he represents at the European Commission in several Eudamed and UDI working groups.  </p><h2>Links</h2><ul><li>Ronald Boumans LinkedIn: <a href="https://www.linkedin.com/in/ronald-boumans-34790055/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/ronald-boumans-34790055/</a></li><li>Emergo website: <a href="https://www.emergobyul.com/" rel="noreferrer noopener nofollow" target="_blank">https://www.emergobyul.com/</a></li><li>Is Switzerland becoming a Third-Country: <a href="https://www.emergobyul.com/blog/2020/01/mdr-watch-switzerland-becoming-third-country" rel="noreferrer noopener nofollow" target="_blank">https://www.emergobyul.com/blog/2020/01/mdr-watch-switzerland-becoming-third-country </a></li><li>Swiss Medtech Letter:  <a href="https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf" rel="noreferrer noopener nofollow" target="_blank">https://3f523920-8cff-4a1c-8866-b188e9556a2b.usrfiles.com/ugd/3f5239_81ac77c6ade747c293171385b289b07b.pdf </a></li></ul><p>The post <a href="https://podcast.easymedicaldevice.com/62/" rel="nofollow" target="_blank">Swixit or not Swixit? this is the question with Ronald Boumans</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/62/" rel="nofollow" target="_blank">Swixit or not Swixit? this is the question with Ronald Boumans</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>

Swixit or not Swixit? this is the question with Ronald Boumans