Easy Medical Device Podcast

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You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the Medical Device made Easy podcast, I have invited Dr. Bassil Akra, the VP of Strategic Business Development at TUV SUD. TUV SUD is one of the biggest Notified Body in the World.

Bassil will explain to us the current situation with Notified Bodies while we have a pandemic where Notified Bodies cannot perform on-site audits but also while we have a 1-year delay for the EU MDR application. So we hope that this episode will answer all your questions and that you will understand why getting an MDD 93/42/EC or AIMDD 90/385/EEC certification is something that is not easy anymore. You will understand also why during the next months you will not be able to issue a new certificate for a new Medical Device.

We will also talk about the “Devil” regulation which is renewing the accreditation of Notified Bodies without following the normal route. And you will understand why it is called the Devil regulation.

In the end, Bassil will also explain to you how it is to work at a Notified Body and all the benefits that you can get. Don’t forget to check the links below for more help.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, Vice President of Global Strategic Business Development for TÜV SÜD Product Service has a background in research, development, regulatory approval, and quality management of medical devices.

Dr. Akra is 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.

Dr. Akra presents worldwide on European requirements and is involved in the development of many guidance documents and standards.

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…

For any Quality or Regulatory Affairs projects, please contact us through the EasyMedicalDevice.com website.

Links

• Dr. Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
• TÜV SÜD link: https://bit.ly/2ZyygJo
• Find a job at TÜV SÜD: https://www.tuvsud.com/de-de/karriere/stellen
• MDCG 2020-4: https://ec.europa.eu/docsroom/documents/40705
• Implementing Regulation 2020/666: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0666&from=EN
• Video: How to become a Notified Body Auditor?: https://www.youtube.com/watch?v=7z7tu-h6ppE

The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast.

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In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is: “How to get ISO 13485 certified?”

As Easy Medical Device is a consulting agency helping Medical Device manufacturers to place compliant medical devices on the market, most of our clients have no experience in the Medical Device Regulations.

So in this video, I will answer this question.

AGENDA

• What is ISO 13485?
• Who can provide this certificate?
• How much does it cost to get ISO 13485 certified?
• Frequency of the audits
• What contains ISO 13485?
• ISO 13485 certified versus US FDA 21 CFR part 820
• ISO 13485 within the MDSAP program
• Easy Medical Device support

Don’t hesitate to reach Easy Medical Device to get some support on your QMS certification process. Or any other Quality and/or Regulatory affairs question.

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, Bausch and Lomb or BBraun Medical, 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 for ISO 13485

• 5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/
• How to verify a certification body?: https://easymedicaldevice.com/accreditation-certification-body/
• Best Tips: ISO 13485 procedures with our free template: https://easymedicaldevice.com/iso-13485-procedure/
• ISO standard: https://iso.org
• Harmonized Standard MDD 93/42/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
• Harmonized Standard AIMDD 90/385/EEC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en
• Harmonized Standard IVDD 98/79/EC: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_fr
• QMS for economic Operators: https://easymedicaldevice.com/economic-operators/
• How to prepare for an Audit article: https://easymedicaldevice.com/medical-device-audit/
• Episode 10 – What is MDSAP?: https://podcast.easymedicaldevice.com/10/
• MDSAP article: https://easymedicaldevice.com/mdsap/
• FAQ article: https://easymedicaldevice.com/faq-iso-13485/

The post How to get ISO 13485 certified? (Quality Management System) 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.

I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast.

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In Germany, a new law was issued for Digital Health Application. To help us understand the content of this law, I have asked Stefan Bolleininger who is helping companies to send an application for it. The name of this application is called DIGA. The acronym will be explained to you in this episode. And we will also explain which app is in and out of scope. What is important to understand if the fact that this law requires you first to be a medical device and then to have your CE mark for it before to get approved for DIGA.

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

• Stefan’s LinkedIn Profile: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Be-on-Quality website: http://www.be-on-quality.com/
• The german law http://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&jumpTo=bgbl120s0768.pdf
• The German Institute https://www.bfarm.de/DE/Medizinprodukte/DVG/_node.html
• The DIGA guidance: https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Beratungsverfahren/DiGA-Leitfaden.pdf;jsessionid=E7B0133B29FAF6555378DC6063271D7E.1_cid507?__blob=publicationFile&v=2

The post How to get your Digital Health Application reimbursed in Germany? (DIGA) 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.

You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change your mind. Listen to Stefan Bolleininger who will explain to you how your customers can get reimbursed. The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast.

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In this episode of the Medical Device made Easy Podcast, we will review;

• How Coronavirus is shaking the Medical Device World?
• The Notified Body Situation
• The Anniversary of the Mini-Course MDR 2017/745
• New MDCG guidance released in April 2020
• All the events that happened at Easy Medical Device Check the links section to find all the sources for the information provided.

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

CORONAVIRUS

• LinkedIn Poll 1 year delay: https://www.linkedin.com/posts/melazzouzi_medicaldevices-eumdr-easymedicaldevice-activity-6657212846474092544-vVKi
• Easy Medical Device Pack Template: https://easymedicaldevice.com/shop
• Commission guidance FAQ: https://ec.europa.eu/docsroom/documents/40607/attachments/1/translations/en/renditions/native
• UK MHRA exemption: https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak
• MHRA flexibility: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19
• Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak
• ISO Standards available during Coronavirus: https://www.iso.org/covid19

NOTIFIED BODY SITUATION

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

MINI-COURSE MDR 2017/745

• Course link: https://easymedicaldevice.com/mdr

MDCG GUIDANCE

• MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-5: Guidance on Clinical Evaluation – Equivalence https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-7: Guidance on PMCF Plan Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-8: Guidance on PMCF Evaluation Report Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-9: Regulatory requirements for ventilators and related accessories https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
• MDCG 2020-3 rev1: Interpretation of Article 54(2)b https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

PODCAST EPISODES

• Episode 71 – MDR & Drug-Device Combination products with Theresa Jeary https://podcast.easymedicaldevice.com/71/
• Medical Device School: Why are Staff hiding problems to QA RA departments with Karandeep Badwal https://podcast.easymedicaldevice.com/mds11/
• Episode 72 – The 1-year Delay of EU MDR 2017/745 with Erik Vollebregt https://podcast.easymedicaldevice.com/72/
• Episode 73 – Calculate your Sample Size with Jon Bergsteinsson https://podcast.easymedicaldevice.com/73/

LINKEDIN LIVE

• How to certify your class Ir Reusable Surgical Instruments (EU MDR 2017/745) https://youtu.be/-sSo-_V0zbY
• Workshop: How to write your Intended Purpose? [Medical Device case study] https://www.youtube.com/watch?v=t4RaJKC9xeM

The post Medical Device News – April 2020 Regulatory Update 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.

Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast.

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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-industry

The post How to calculate your sample size with Jon Bergsteinsson 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.

Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some examples in the ebook provided by Jon. The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast.