Easy Medical Device Podcast

https://www.youtube.com/embed/y4mW9KdAuU8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes which are Class I sterile (Is), Class I with a measuring function (Im) and the new Class I for surgical reusable devices (Ir). When class I products are Self-Certified, you should know that this is not the case for class I special devices.

Elem Ayne from ACR Medical will help us understand the difference and what should be done to have compliant medical devices. She will also tell you what will be checked during an audit. This part is really important. Don’t forget also to download the presentation that Elem prepared for you.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France). She has 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 herself in Regulatory affairs working especially in Class I reusable granted by 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.

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

• Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/
• Presentation to download: https://mailchi.mp/easymedicaldevice/class_i_special

The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you should prepare to be compliant. The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/qdSq2jO7WEQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Let’s see if what is shown in movies is correct. Can some hackers take control of a Hospital or kill you by hacking an insulin pump. Is this science fiction or reality. In this episode of the Medical Device made Easy Podcast, we will focus on cybersecurity for Medical Devices.

The new Medical Device Regulation is providing more information on Softwares and this is due to the progress done which can then lead to some issues. Erik Vollebregt will be my guest on the podcast to explain to us:

• What manufacturers should do to comply with the regulations?
• Which guidance they should follow?
• Is it the same in all the countries?

Don’t forget to look at the links with all the guidance that we discussed today.

Who is Erik Vollebregt?

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

Links

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Erik’s blog post on Cybersecurity: https://medicaldeviceslegal.com/2020/03/16/the-mdcg-cybersecurity-guidance-a-helpful-rush-job
• MDCG 2019-16: https://ec.europa.eu/docsroom/documents/38924
• ENISA handbook: https://www.enisa.europa.eu/publications/handbook-on-security-of-personal-data-processing
• IMDRF Principles and Practices for Medical Device Cybersecurity: http://www.imdrf.org/consultations/cons-ppmdc.asp
• BSI cybersecurity for devices white paper: https://www.bsigroup.com/en-US/medical-devices/Resources/Whitepapers-and-articles/

The post Cybersecurity for your Medical Devices with Erik Vollebregt 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.

Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how to secure your medical devices if they are connected to a network. The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/kYcs6PXM0tA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

On this Regulatory Update, we will talk about many diverse topics but here is an outline.

First, we will review the Coronavirus situation and I will also provide you with some fun facts that are happening.

Then we will talk about MDCG committee. We’ll review the guidance issued and the topics they will discuss during this march meeting.

After that, we will discuss the Notified Body Situation. How many are available? Who are the new ones?

Finally, we’ll review some US guidance that are issued and even a Ban of a certain device.

I will also take the opportunity of this review to review all the topics that were discussed on the podcast, and also the LinkedIn Live.

I really hope this will be informative to you.

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

• MDCG Meeting March 12th, 2020: https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=39327
• Notified Body Norway – DNV GL Presafe AS https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=304712&version_no=4
• Notified Body Ireland – NSAI https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=304908&version_no=9
• Soft (Hydrophilic) daily Wear Contact Lenses (Draft Guidance) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/soft-hydrophilic-daily-wear-contact-lenses-performance-criteria-safety-and-performance-based-pathway
• Guidance Bone Anchors – 510k Submission https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bone-anchors-premarket-notification-510k-submissions
• Ban of Electrical Stimulation Devices (ESDs) for self-injurious or aggressive behavior https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior
• TOPRA course: https://www.topra.org/TOPRA/TOPRA_Member/Events/Event_Display.aspx?EventKey=MC142020
• Podcast episode 62 – Swixit: https://podcast.easymedicaldevice.com/62/
• Podcast episode 63- Brexit, Swixit, Turkxit: https://podcast.easymedicaldevice.com/63/
• Podcast episode 64 – Clinical Data low-risk device: https://podcast.easymedicaldevice.com/64/
• Podcast episode 65 – Intended Purpose: https://podcast.easymedicaldevice.com/65/
• LinkedIn Live – QMS Implementation for MDR Up-classified Software Medical Devices: https://www.youtube.com/watch?v=HYZJn23C3oc
• LinkedIn Live – ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
• LinkedIn Live – Annex XVI: https://www.youtube.com/watch?v=kpIphE2PVew
• Easy Medical Device Shop: https://easymedicaldevice.com/shop

The post Medical Device Regulatory Update – February 2020 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 episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it. The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/3FgLMtta4rM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We know that the Manufacturer of a Medical Device needs a Quality Management System, but what about the Importer, Distributor or Authorized Representative? Do they also need to show they have a system that guarantees that what they are distributing is correct? Erik Vollebregt from Axon Lawyers will help us understand what is written on the different texts. The answer is not easy as there is what is mandatory by EU MDR 2017/745 or EU IVDR 2017/746 and what is common sense. Can you be blamed because you don’t have an ISO 13485 certification? Don’t forget to review the other episodes related to Economic Operators to have a full view of the process.

Who is Erik Vollebregt?

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 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: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyer website: https://www.axonlawyers.com/
• Bonus Episode 9 – What is the responsibility of Economic Operators: https://podcast.easymedicaldevice.com/mds9/
• HPRA Distributor Guidance: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13

The post Do your Economic Operators need a 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.

It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation. The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast.

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

As Cesare Magri said, the intended purpose is not really a priority for some companies so they don’t take to much time to write them. But you will hear in this episode why it is clearly a strategic task for your company.

When you are creating your EU MDR 2017/745 technical documentation, you have to also define some scope for your product. And it is the objective of the intended purpose.

Cesare Magri from be-on-Clinical (which is related to be-on-Quality) is helping companies and he sees a lot of examples of issues related to the intended purpose. He will share with us the different steps needed to build your intended purpose and he will offer also a document to download that can be used to brainstorm regarding your intended purpose with your team.

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. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.

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

• Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri-92465345/
• Download Presentation: https://mailchi.mp/easymedicaldevice/intended_purpose
• Check the Easy Medical Device Shop: https://school.easymedicaldevice.com/shop/
• Episode 40 – How to perform Product Equivalence on your CER?: https://podcast.easymedicaldevice.com/40/

The post Create your intended purpose with Cesare Magri (Medical Device) 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.

The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how to create it correctly. The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast.