Easy Medical Device Podcast

This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We’ll try to give you some advice on how to overcome this situation.

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

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

• Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
• The Medtech Podcat: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3
• QRA Medical Youtube video: https://www.youtube.com/channel/UC1ygqJO7_HV30XVdHyN-0lg

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

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

This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation... So if you want to avoid these issues don't miss this episode as they can cost you time and money.

 Who is Adam Isaacs Rar? 

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

 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: 

• LinkedIn profile Adam Isaacs Rae:  https://www.linkedin.com/in/adam-isaacs-rae/
• Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

 Social Media to follow

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

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

Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules. But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming.  

So let’S discuss that with Claire Dyson 

Who is Claire Dyson? 

Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/

UK transition timelines: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

UK transition rule: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations 

UK medical device regulation: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_theUnited_Kingdom.pdf 

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/easymedicaldeviceAuthorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf

• MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf

•Finland - Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023

•France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques

• Switzerland - IVD performance studies : https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf

•Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html

• UK - Transition from CE to UKCA :https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

• Training EU MDR :https://school.easymedicaldevice.com/course/gb25 

USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program.

o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India :

o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars :

•May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229

•May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228

oPodcast Nostalgia

•Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/

•Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/

•Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/

Ask Easy Medical Device . We can help you

•Contact at [email protected]

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.

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster.

Waterfall? Agile? … The methodology to develop a Software are multiple but you need as a company to define it prior to the project so you have the right pathway to follow. And in this episode of the podcast we will help you transition to the AGILE methodology for Software development. This is a well known method but we’ll try also to explain its advantages and also look at the way for you to transition to it. Bence and Attila from IronRooster will be my guests and they will tell you the tips an tricks about Agile development

Who is Bence Török?

I am Bence, a proud member of the Iron Rooster team for two years now, spending most of my time trying to improve a MedTech project. I began my journey in the IT field as a technical writer working on Telecommunication projects, but after joining Iron Rooster, I quickly realized that project management was where I wanted to focus. Therefore, I delved into it and continue to expand my knowledge each day. Currently, I manage several MedTech projects and work with excellent software professionals in the blood banking industry, where we cover everything from donor recruiting to laboratory testing.

Who is Attila Katona?

My name is Attila, and I am a senior member of the Iron Rooster team. I have been a long-time (tor)mentor for my merry team of quality assurance and regulatory compliance experts in our medical software development company. Over the years, I have been involved in 50+ projects in half a dozen different roles, performing various roles ranging from requirements engineering and test management to designing complex product documentation processes and full QMS maintenance.

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

IronRooster Linkedin page: https://www.linkedin.com/company/ironrooster/

Bence Linkedin Page:

Attila Linkedin Page:

IronRooster website: https://ironrooster.io/

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

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

If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal. 

An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO audit, MDSAP audit, Supplier audit … You’ll have to go through this within many occasions so be ready for it.

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

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

Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/

Easy Medical Device blog on audit: https://easymedicaldevice.com/internal-audit/

Podcast episode on audit: https://podcast.easymedicaldevice.com/175/

Video on internal audit: https://www.youtube.com/watch?v=UA_J_WXLPag&pp=ygUiZWFzeSBtZWRpY2FsIGRldmljZSBpbnRlcm5hbCBhdWRpdA%3D%3D

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

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

in this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product. SOUP is the acronym for Software Of Unknown Provenance. This is mainly a piece of software that you want to use on your Medical Device but that you have not developed yourself. So if you have such thing, then you need to listen to this podcast episode with Christian Kaestner from Medical Device HQ.

►Who is Christian Kaestner?

Christian Kaestner is a highly skilled professional with over 25 years of experience in the medical device field. As a software developer with a deep interest in medical device software, Christian has the technical background to understand software development. Christian was on the project teams that authored IEC 62304 and IEC 82304-1, so he has in-depth experience working with standards. If you're looking to improve your team's knowledge and skills, Christian offers online courses through Medical Device HQ to keep you up-to-date with industry best practices. He can also guide you in setting up your development process to comply with relevant standards. Visit medicaldevicehq.com to learn more, and feel free to connect on LinkedIn.

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► 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.

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► Links from the Video

■LinkedIn: https://www.linkedin.com/in/christiankaestner/

I’m happy to answer short follow-up questions through LinkedIn messages.

■Blog post on how to manage SOUPs: https://medicaldevicehq.com/articles/managing-and-documenting-soup-and-ots-in-medical-device-software/

■Medical device resources on YouTube: https://www.youtube.com/medicaldeviceHQ Playlist with medical device software videos on YouTube:

https://www.youtube-nocookie.com/embed/videoseries?list=PLHbDOHytLFxGSmU8aiSWXskPN0qZv0VPg

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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

► Podcast page: https://podcast.easymedicaldevice.com/226-2/

► Medboard platform: https://www.medboard.com/

► MEDBOARD SHOW NOTES LINKS: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/

Today on this Medical Device news for april 2023 we’ll talk about

• The EU MDR Extension vote https: //health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a.pdf

• The Notified Bodies that are certified https: //www.team-nb.org/frequency-of-complete-re-assessments-of-notified-bodies/

• The changes in EU spain, UK, Switzerland, Belgium https: //www.sfda.gov.sa/sites/default/files/2023-03/MDS-G012A.pdf

• But also Middle East, USA, Brazil. https: //www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/consumidor-ganha-plataforma-para-notificacao-de-eventos-adversos

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► 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.

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► Links from the Video

-MEDBOARD SHOW NOTES LINKS:: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/

- Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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

In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”. If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk Management for Medical Devices”. Link below.

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►Who is Bijan Elahi?

Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s. Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.

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►Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

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Link:

- Bijan Elahi LinkedIn Profile:https://www.linkedin.com/in/bijanelahi/

- Book: “Safety Risk Management for Medical Devices”

- Episode 207: Why Risk Management is important to Medical Device development: 

https://www.youtube-nocookie.com/embed/cFmVpYkQ0wk?feature=oembed

- Episode 216: How to evaluate Benefit-Risk ratio for Medical Devices?:

https://www.youtube-nocookie.com/embed/7fimKKqBtEY?feature=oembed

- Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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