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, PhD 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.

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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. 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

• Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri-92465345/

This month we will have some updates on:

• Annex XVI

Enjoy!

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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. 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

• Links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/

We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team-PRRC conference and what will be talked about during that event. Join us if you are in the region.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of the “DM Experts” network (in France). She started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization. She has finally specialized in Regulatory affairs working especially in Class I reusable granted a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745. She is also the President of the Non-for-profit association Team-PRRC

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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. 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 

• Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne

Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:

• What is MDSAP?

Don’t hesitate to check the links below to find more resources to help you.

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 notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built 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 has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

• MDSAP blog post: https://easymedicaldevice.com/mdsap/

Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video.

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… Is company are also acting as Authorized Representative for 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

• Medboard regulatory links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/

This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I also asked some of my team members to tell me what their journey was since they are part of the team.

So today, this is the result of the feedback and I also wanted to thank all the listeners as this journey would not have been achieved without you. Thanks for your comments, and your nice messages.

So let’s meet who is behind Easy Medical Device as I am not alone.

Links

• Alex Despotovic Linkedin: https://www.linkedin.com/in/alex-despotovic

Social Media to follow

• ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects.

There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions.

To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR

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 is also acting 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

• NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

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&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&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

• Boumans Regulatory Consulting website: https://boumansconsulting.com/

You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these products. And this is what we will explain to you today on this podcast episode. Stéphen Toupin from Dawa Medical is helping those manufacturers by being their Initial Importer and he will tell you what you should do to remain compliant.

Who is Stéphen Toupin?

Over the last 27 years, Stéphan has gained a wealth of experience in the Medtech and pharmaceutical industries with Astra Zeneca, Biovail, and Novo Nordisk. Stephan founded Dawa Medical in 2015 to collaborate with foreign MedTech manufacturers to enter and succeed in the massive US market. Dawa Medical is a United States Initial Importer and FDA agent, with warehousing and distribution capabilities. Dawa Medical also offers services for the Canadian and Latin American markets.

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 notably 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 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

• Stéphen Toupin LinkedIn Page: https://www.linkedin.com/in/stephantoupin/

Here are the links to the Regulatory Updates

HOT TOPIC

• EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf

ROW

• SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146

TRAINING

• Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/

NOTIFIED BODIES

• 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15

GUIDANCES

• MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf

EASY MEDICAL DEVICE PODCAST

• Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/