Medical Device made Easy Podcast easymedicaldevice

EUDAMED is the European Database for Medical Devices. In this episode Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 asks you to register your company, your products in this database.

Who is Richard Houlihan?

Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.   His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.

 

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.



Link:



Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/



EUDAMED.Com website: https://eudamed.com/



EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home



EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/



EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html



EMDN Code Website: https://webgate.ec.europa.eu/dyna2/emdn/ Meeting Minute EUDAMED timeline: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=48063&fromExpertGroups=3565



Playground: https://webgate.training.ec.europa.eu/eudamed-play



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

In this second part of this podcast serie on Team-Prrc interviews. we have 3 additional guests. Don't miss the first one where we also got great interviews. In this episode, we will interview - Bassil Akra about the Team-PRRC event and why you should come. This will happen again November 16th and 17th.



- Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company



- Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company



- Elem Ayne, the Team-PRRC presidente who will explain to us more about the event and how this first session went.



So don't miss the next opportunity to meet everyone at the Team-PRRC event in Strasbourg - France on November 16th and 17th. You'll be able to create a great network.



Links from the Video



Bassil Akra Linkedin: https://www.linkedin.com/in/bassil-akra-akrateam/



Elena Kyria Linkedin: https://www.linkedin.com/in/elenakyria/



Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne/



Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation



Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU



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

Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different economic operators The second one with Erik Vollebregt where we will review the role of a PRRC and liability The third one with Ronald Boumans where we will explain how to behave to be a PRRC And the last one with Christopher Kipp from BVMed on the PRRC role in Germany with the already existing safety officer. Don’t miss the next Team-PRRC event November 16-17 2023 in Strasbourg.



Links



Piero Costa LinkedIn Page: https://www.linkedin.com/in/pierocosta1980

Erik Vollebregt LinkedIn Page: https://www.linkedin.com/in/erikvollebregt/

Ronald Boumans LinkedIn Page: https://www.linkedin.com/in/ronald-boumans/



Christopher Kipp Linkedin Page: https://www.linkedin.com/in/christopher-kipp-b16ba71b1/

Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation

Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU



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

EU

o MDR and IVDR communication Survey

• EU MDR transition

• Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf

• Flowchart to decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf

o Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf

• Blog Post - Erik Vollebregt . Can we fix/improve the MDR and the IVDR? : https://medicaldeviceslegal.com/2023/08/29/can-we-fix-improve-the-mdr-and-the-ivdr/

 

• Team-NB: Transfer agreement :https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-TransferAgreement-V1-20230811.pdf

• Notified Bodies situation :https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf

• EMA consultation: https://www.ema.europa.eu/en/documents/other/questions-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary_en.pdf

Training offered:

• Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/

•Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

• Green Belt: https://school.easymedicaldevice.com/course/gb26/

UK:

o CE Marking recognition: https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=70128116-5d7a-4e60-89d6-99e578f8a33b&utm_content=immediately

• Ronald Boumans article: https://www.linkedin.com/posts/ronald-boumans_ukca-maring-for-medical-devices-and-ivds-activity-7092405961541185536-bfRY?utm_source=share&utm_medium=member_desktop

• Guardian article: https://www.theguardian.com/commentisfree/2023/aug/04/business-brexit-safety-mark-red-tape-?mibextid=Zxz2cZ

• Guardian article: https://www.theguardian.com/politics/2023/aug/08/left-in-limbo-by-brexit-safety-mark-chaos?mibextid=Zxz2cZ

 

o 3 new UK Approved bodies :https://www.gov.uk/government/news/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra

• Approved Body list: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

 

TGA:

Webinar :

The new Medical devices Vigilance Program- Information for medical device Sponsors in

•Australia: https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia

• UDI: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved

 

Canada:

o Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html

USA:

o Off-the-Shelf Software :https://www.fda.gov/media/71794/downloadSaudi Arabia:

o ISO 13485 for manufacturers & supplies facilities : https://www.sfda.gov.sa/sites/default/files/2023-08/MD-Quality13485.pdf

eQMS:

o SmartEye : https://smart-eye.io

Conferences

o MEDXD - Berlin Germany September 26 and 27- : https://medtechx.digital/

• Afrisummit - Cairo Egypt : https://www.pharmaregafrisummit.com/meddev/

• MEDICA - Dusseldorf Germany : https://www.medica-tradefair.com/

• Team-PRRC - Strasbourg France : https://www.team-prrc.eu/page/1111392-presentation

Podcast to listen :

• Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/

• The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3

• The Med-Tech Talent

Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues…



So let’s listen to Enrico Allegra from TestLabs who will share with us his experience.



Who is Enrico Allegra?



Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings.



He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women.



He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist.



The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models.



The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients.



He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports.



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.



Links from the Video



■Enrico Allegra LinkedIn: https://www.linkedin.com/in/enrico-allegra-b97751164



■TestLabs LinkedIn Page: https://www.linkedin.com/company/testlabsuk/



■TestLabs webpage: https://testlabsuk.com/



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/easymedicaldev

We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the crosses.

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. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.

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:

-Cesare Magri Linkedin : https://www.linkedin.com/in/cesare-magri/ 4BetterDevices

-LinkedIn Page: https://www.linkedin.com/company/4betterdevices/

-Website 4BetterDevices: https://4betterdevices.com/

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