Easy Medical Device Podcast

https://www.youtube.com/embed/XgtVuDytZwQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Subscribe

I am sure you were once on this situation where you started to develop a Medical Device and when you finished all the tests, and estimate that your product is good, then you want to put it on the market. When regulators ask you for your design documentation your mind then has a bug.

On this bonus episode of the Medical Device made Easy Podcast, Stefan Bolleininger, and Monir El Azzouzi will explain to you when you should develop first your product and when you should develop your documentation.

This episode can save you some time and understanding of the process. So don’t miss it

Who is Stefan Bolleininger?

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.

He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.

In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

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

• Easy Medical Device: https://easymedicaldevice.com
• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Medical Device Startups – Here are the secrets of success: https://www.medicaldesignandoutsourcing.com/medical-device-startups-secrets-success/
• 5 FDA Myths that Startup believe: https://podcast.easymedicaldevice.com/45/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast. The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/Mysvn6sg5dE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Subscribe

In this 50th episode of the Podcast, we will talk about the announcement that was made this November 2019 by the European Commission of the EUDAMED Delay.

Richard Houlihan, CEO of EUDAMED.EU is my guest and will help us understand the situation and what should be done.

If you remember, Richard was on episode 25 of the podcast.
■ https://podcast.easymedicaldevice.com/25
All that Richard shared on this episode is still relevant. So don’t hesitate to listen back to it.

One conclusion of this episode is the fact that EUDAMED is delayed but MDR 2017/745 is not so you should continue your transition.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups and 3 different directorates within the European Commission.

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

• Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/
• Eudamed.eu Website: https://Eudamed.Eu
• EU commission news about the delay: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
• Eudamed Cheat Sheet + Promo Code: https://mailchi.mp/easymedicaldevice/eudamed_delay
• UDI article: https://easymedicaldevice.com/udi/
• Episode 4 – UDI: https://podcast.easymedicaldevice.com/4/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/KayuIRgD8ac?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Subscribe

As I have performed some Literature Searches and created some CER myself, I know the difficulty and time of doing that. But I also had to audit some CER reports and I am always surprised by the way this is done. With the new Medical Device Regulation EU MDR 2017/745, you will maybe have to update your CERs so this is why I decided to focus on this topic for this episode.

To help you perform your CER if they are based on Literature Search, I asked Ed Drower, Director of Regulatory Affairs at CiteMedical Solution, to come to explain to us the best practices to look for your Literature and how can you check that they are the most relevant for your Clinical Evaluation Report.

In this episode, we will also discuss timing to perform CER and Ed will share with us what Cite Medical Solution can propose to its customers. On the links below, Ed accepted to share some examples on how to create a CER.

In case you need more information on Clinical Evaluation Reports or CER, I propose you to listen again to the Podcast episode made with Helene Quie from Qmed Consulting. This is also one of the most listened episodes.

Who is Ed Drower?

Ed Drower is the Director of Regulatory Affairs at CiteMedical Solutions.  In his last 10 years, he has supported filings and reviews of individual medical devices and combination products both in the US and Europe. 

With decades of clinical research and drug development experience, Mr. Drower provides a broad perspective to regulatory compliance, document review, and preparation, as well as offering, managed solutions for the upcoming MDR release.

His company CiteMedical Solution is also helping its customers to perform the Literature Search described in this episode so don’t hesitate to contact them.

Links

• Ed Drower Linkedin Profile: https://www.linkedin.com/in/ed-drower-1108a2a/
• Cite Medical Solution: https://CiteMedical.com
• Download free samples of CER: https://www.citemedical.com/easymedpodcast/
• CER – Product Equivalence with Helene Quie: https://podcast.easymedicaldevice.com/40

The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from CiteMedical Solution The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/_8hP1NWz5rY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Subscribe

On this Bonus Episode of Medical Device School, we talk about Gap Assessment with Stefan Bolleininger.

What do you understand when we say that you should perform a Gap Assessment? Which tools should you use for a Gap Assessment? We will give you our opinion but we really want also to hear from you.

In this episode, Stefan says also that we should not use Excel for a Gap Assessment tool. And that you should not mix Gap Assessment and Project activities.

We will also discuss the General Gap Assessment tools and the fact that your company is unique. So you should always adapt the tools you get to match your company structure. So much said in a few minutes.

On the links below, we propose some general Gap Assessment tools with the collaboration of the Regulatory Globe. Don’t hesitate to check the affiliate link in case you are really looking for something already built for you.

Link to the episode

• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Be-On-Quality Website: https://www.be-on-quality.com/
• Gap Assessment Tools: https://www.regulatoryglobe.com?ref=1133
• Medical Device School – CAPA issues: https://podcast.easymedicaldevice.com/mds1/

The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap assessment. To check where you are and if you are compliant to where you want to be. Let'S see if you follow our discussion with Stefan Bolleininger. The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/uzLpLsxECG8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Subscribe

After eQMS implementation, we talk this week about eQMS validation and Jacob Sjorslev from SimplerQMS is really providing some great value by answering all the questions that a Medical Device Company should ask when having such software.

The validation of an electronic Quality Management System (eQMS) is not the same as for a product. There is a specific standard dedicated to this case and Jacob will help you understand it.

When you listen to Jacob you can feel that he is really passionate about what he is doing and the way he explain the different processes make real sense. I liked it when he said that a Medical Device manufacturer should not start with an eQMS but with paper. This is not something that you hear from another software developer.

Who is Jacob Sjorslev

Jacob has been the VP of Business IT in a global medical devices company and started his career in business development and later became a project- and program manager.

Challenging local autonomy and willingness to change Jacob has been successful with a large portfolio of global digital transformation projects that have created common best of breed systems, best practice processes and a rock-solid method for implementing projects in the USA, Asia and the EU on time.

The results are optimized common processes, outsourcing of services, integrations with customers, external warehouses and suppliers and fast integration of acquired companies. The projects have contributed to growing the turnover with 250%, 650% on profit and 2500% on the share price.

The digital transformation experiences are now available for supporting Medical Device Startups with a cloud-based preconfigured and prevalidated eQMS system based on M-Files in Jacobs own company SimplerQMS.

Link to the episode

• Jacob Sjorslev LinkedIn: https://www.linkedin.com/in/jacobshyrdum/
• SimplerQms Website: https://www.simplerqms.com/
• eQMS validation pdf to download: https://mailchi.mp/easymedicaldevice/eqms_validation_giveaway
• Episode 11 – Software Validation: https://podcast.easymedicaldevice.com/11
• Episode 29 – 5 steps to create a Quality Management System: https://podcast.easymedicaldevice.com/29/

The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway, The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast.