Easy Medical Device Podcast

https://www.youtube.com/embed/4NS7WjmetgM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The EU MDR 2017/745 is increasing the requirements for Clinical Evaluations. In this episode, I will be with Dr. Bassil Akra from QUNIQUE and we will explain to you the different levels of reviews that exist and specifically about the Expert Panel.

You would maybe ask “What is this?”.

Don’t worry, we will explain to you and even provide you with more information also on some voluntary consultation that this group can provide.

In case you need some support for your Clinical Evaluation Reports, UK responsible process, Technical File review, Training for EU MDR, don’t hesitate to contact us at [email protected] We can guide you on this process.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group has a background in research, development, regulatory approval, and quality management of medical devices.

Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020.

In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.

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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
• QUNIQUE Group: https://quniquegroup.com/
• EXPERT PANEL EU: https://ec.europa.eu/health/md_expertpanels/overview_en
• MDCG 2020-13: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-13-cea-report-template_en.pdf
• Episode 78 – Sufficient Clinical Data: https://podcast.easymedicaldevice.com/78

The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/_5bdNbG1MyY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan Bolleininger. In the EU MDR and IVDR, Common Specification is mentioned and it is a tool that the EU Commission can use.

But are you obliged to use them? In this episode, we will talk about a few common specifications. 1 published, 1 under draft, and some that are supposedly planned.

And we can see also that some of the provisions of the EU MDR cannot be applied without the publication of some common specifications.

So even if you think you are not impacted by Common Specification, you maybe need to re-evaluate that after listening to this episode.

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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Be-on-Quality website: http://www.be-on-quality.com/
• Common Specifications 2020/1207: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj
• Annex XVI Live session: https://youtu.be/kpIphE2PVew

The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come. The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/kuTOkLY4CNY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We have reached Episode 100 and when I am looking back, I can see that there were a lot of things done. But instead of me telling you only my story, I have decided to invite some of my guests to tell us also their stories from the last 2 years.

So, I will introduce you 5 stories from 5 influencers in the Medical Device field.

• Erik Vollebregt – Partner at Axon Lawyers
• Bassil Akra – CEO and co-owner at QUNIQUE Group
• Stefan Bolleininger – CEO at Be-on-Quality
• Martin Witte – Sr. Director Business Development at TÜV SÜD
• Richard Houlihan – CEO at EUDAMED.EU

If you also want to share with us your highlight for the last 2 years, don’t hesitate to put that on the comments.

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

• Erik Vollebregt: https://www.linkedin.com/in/erikvollebregt/
• Bassil Akra: https://www.linkedin.com/in/bassil-akra-2388b84b/
• Stefan Bolleininger: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Martin Witte: https://www.linkedin.com/in/martin-r-witte/
• Richard Houlihan: https://www.linkedin.com/in/richard-houlihan/

The post We’ve reached episode 100 – What happened for the last 2 years? 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.

We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years. The post We’ve reached episode 100 – What happened for the last 2 years? appeared first on Medical Device made Easy Podcast.

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

We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing devices under IVDR. Self-tests or near-patient tests are problematic because they are used by laypersons which are not professionals on the way to use or interpret the result of such a device.

So, some particular care is provided by the regulators to verify that a layperson really understands how these device work and to avoid some misinterpretation.

Erik Vollebregt will be helping us to understand this situation and we will also talk about certain stories we were experimenting with.

Who is Erik Wollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A.

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission.

He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology.

Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

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 has 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

• Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: http://www.axonlawyers.com/
• Presentation to download: https://mailchi.mp/easymedicaldevice/g5poc37919
• Episode 42 – New rules for the IVD industry with Maurizio Suppo: https://podcast.easymedicaldevice.com/42/

The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that. The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/A6rkJAO8Vkw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Catherine Higginson from Climedo is coming on the Podcast to present us one study they have issued which will tell you more about the Cost of EU MDR but not only that.

This is showing the investment that companies are doing regarding EU MDR:

• Time investment
• Resource investment
• Money investment

It is also showing some data related to the digitalization of their companies regarding some activities like the collection of Clinical Data. Some of them are still using Excel to do that which is maybe not the most convenient solution.

You will have access to this survey by checking the links below.

About Climedo Health

Climedo’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products. By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals, and patients), Climedo allows for increased performance, better cost-efficiencies – and ultimately – accelerated medical innovation.

Who is Catherine Higginson?

Catherine started her career in the SaaS field in Corporate Communications for a B2B online language training company where she managed the company’s global marketing and PR activities. After almost four years, she switched to strategy consulting firm Oliver Wyman to help drive the company’s digital marketing and employer branding mission within Europe. In 2019, she joined Climedo Health, a software company that helps MedTech companies collect clinical data on their medical devices with the help of cloud-based solutions. As a bit of a “newbie” to the healthcare sector, she has enjoyed the steep learning curve offered by the startup world and creates regular content to help educate MedTech companies on matters such as electronic data capture and the EU MDR. She also carries out market research to assess the state of the industry in terms of MDR preparation and costs. Catherine studied Modern Languages (French and Spanish) at Newcastle University, followed by a Masters’s degree in Management at Warwick Business School.

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

• Catherine Higginson LinkedIn Profile: https://www.linkedin.com/in/catherine-higginson/
• Climedo Website: https://climedo.de/en/
• Survey result – Cost of EU MDR: http://bit.ly/EU-MDR-Costs
• Episode Digitalization: https://podcast.easymedicaldevice.com/35/
• Green Belt Certificate: https://school.easymedicaldevice.com/gb

The post What is the cost of EU MDR 2017/745? [Catherine Higginson] 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.

EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to understand what you can expect from this type of projects. The post What is the cost of EU MDR 2017/745? [Catherine Higginson] appeared first on Medical Device made Easy Podcast.