Easy Medical Device Podcast

EU

Manual on Borderline and classification for Medical Devices Update - New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf

Q&A on Annex XVI Products - Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf

Italy: Custom-made medical device registration - Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352

Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0

Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/

Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/

FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland

UK

The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

CH

Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024:  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf

Conferences

Which conferences to focus on?  - I will be going to them so join me.

MEDXD: Digitalisation of Medtech: https://medtechx.digital/

Afrisummit in Egypt:  https://www.pharmaregafrisummit.com/

Medica: https://www.medica-tradefair.com/

Team-PRRC: https://www.team-prrc.eu/

Training

Trainings for you - Self-paced

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

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

US

US FDA - De Novo Request - Electronic Submission template: https://www.fda.gov/media/172450/download

Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content

Webinar US FDA  - Breakthrough devices program update - November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023

Digital Health FAQ - Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs

ISO 10993-1:2018 versus FDA - FDA is adding its touch: https://www.fda.gov/media/142959/download

Best practice for selecting a Predicate device for your 510K - Method provided. https://www.fda.gov/media/171838/download

Saudi Arabia

SFDA Significant changes guidance - Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf

Malaysia

Malaysia: Workshop preparation of documents for Submission -  October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html

Turkey

Mutual Recognition of Authorized rep and NB in Turkey - Good clarification:  https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242Japan

Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf

India

India: List of registered medical device testing laboratory - under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE=

Podcast

Podcast Nostalgia - Do you remember?

Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/

and 250: part 2: https://podcast.easymedicaldevice.com/250-2/

Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/

QMS

How Easy Medical Device can help you -easymedicaldevice.com

We can also help you implement our eQMS - Smarteye: https://smart-eye.io

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

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

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

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

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

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

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

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 Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OPbgsS6DqhCZuAFG2• Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900

• State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6

Podcast Nostalgia

• Who should be on your Risk Management Dream Team with Naveen Agarwal:  https://podcast.easymedicaldevice.com/243-2/

• Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com/244-2/

• Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com/245-2/

• What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com/246-2/

• How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com/247-2/

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

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/easymedicaldevice

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

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

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

Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data. 

In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that you can automate your validation and you don’t need to test everything manually. That would save you a lot of time. But what are the benefits or pitfalls of it?  

Don’t miss this episode if you are in software development or if you use Software to manage quality data. 

Who is Christophe Girardey? 

Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. 

Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. 

Who is Virginie Rochat? 

Virginie is leading the Test Automation team at wega, a life science consulting company specialized in digitalization. The Test Automation team is composed of people with a broad range of backgrounds -  from software and testing engineers to QA and Validation specialists - in order to support Pharmaceutical and Medical Device companies when it comes to automate end-to-end testing. With its expertise in user interface test automation tools, wega can support you through the selection of the proper tool based on your needs and infrastructure, validate the tool and then help your teams into the development of automated test cases and provide the necessary experience to support your team to reach compliance in a more efficient way. 

Virginie has more than 10 years of experience within pharma laboratories. She has always been keen to automate repetitive tasks and prone to adopt new technologies to improve the efficiency of the business processes, leading her to develop more and more knowledge on informatic and technologies, to bridge the gap between Science and IT. 

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: 

Article on Test Automation: https://www.wega-it.com/en/automatisierung-von-softwaretests-fuer-nutzeranforderungenChristophe

Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/

Virginie Rochat Linkedin: https://www.linkedin.com/in/virginie-rochat86/

wega Website : https://www.wega-it.com/ 

Medical Device: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance 

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.

Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you in the podcast episode.  

Mitch Robbins is a professional recruiter that has its own agency “The Anthony Michael Group”. He is able to help you on your research as he is specialised in QA RA recruitment. But he also knows your pain when your company cannot hire a recruiter for this mission. So, we will review what he proposes to you to be successful regarding this challenge. 

Who is Mitch Robbins? 

Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions. 

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: 

Mitch Robbins Linkedin : https://www.linkedin.com/in/mitchrobbins 

Linkedin Post: https://www.linkedin.com/posts/mitchrobbins_regulatoryaffairs-hiring-theanthonymichaelgroup-activity-7076976156570243073-kEsY/

 Podcast Med-Tech Talent Lab: https://spoti.fi/3LqqubL The Anthony Michael Group website: https://www.theanthonymichaelgroup.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

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

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that. 

Who is Naveen Agarwal? 

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. 

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: 

Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/

Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt 

Achieve Website: https://www.achievexl.com 

Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.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

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.