195 episodes

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

Medical Device made Easy Podcast easymedicaldevice

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    • 4.8 • 6 Ratings

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

    Attention! 1 year before UKCA is the law for Medical Devices in the UK

    Attention! 1 year before UKCA is the law for Medical Devices in the UK

    This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what Adam Rae will tell you.

    We will mention the rules for UKCA, the documentation needed for the Approved Body situation, and also the Northern Ireland Situation.

    So no need to read all the regulations, we will summarize the situation here and you will need to act immediately after that.

    Who is Adam Rae?

    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 the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

    Links

    LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/

    Website: theotherconsultants.com

    Substack newsletter: https://theotherconsultants.substack.com/

    Download cheat sheet: https://mailchi.mp/easymedicaldevice/podcast-episode-186-ukca

    Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]

    Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]

    When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical Device Economic Operators.



    In this episode, Cristina Miroescu (Compliance Director at Sofmedica) will explain to us why Sofmedica decided to be ISO 13485 certified. You'll hear about their journey with the Plus and Minus. We are sure this may help you understand the process of certification if you are an importer or distributor.



    Who is Cristina Miroescu?



    Cristina joined SofMedica in 2000 as the first regulatory person preparing files for medicinal product and medical devices registration. Later on, as Regulatory Manager her role was to integrate the legal provisions and regulations into the company’s business strategy.



    She used to manage quality management systems, vigilance, pharmacovigilance, regulatory, compliance, and warehouse management. As a Group Compliance Director Cristina is responsible to ensure the compliance of the company’s activity with the applicable legislation and requirements with a focus on contributing to building a quality culture of integrity, transparency, and honesty.



    An important part of Cristina’s activity was focused between 2010 – 2015 in the medical services field in another company of SofMedica group when she was managing the quality management system, permits obtaining and maintenance for 15 dialysis centers in Romania. Cristina holds a bachelor’s degree in Pharmacy.



    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 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, podcasts, online courses...



    Links



    Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164/

    Sofmedica website: https://sofmedica.com/

    Video Sofmedica:

    How to avoid these common mistakes on your Quality System? [Karandeep Badwal]

    How to avoid these common mistakes on your Quality System? [Karandeep Badwal]

    In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs.

    Software validation

    Supplier evaluation

    Clear procedures

    Internal audits

    CAPAs

    SaMD

    Vigilance reporting

    Standards

    Unannounced audits



    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 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, podcasts, online courses...

    Links

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

    Youtube channel: https://www.youtube.com/c/QRAMedical

    Podcast:




    Social Media to follow

    Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

    Twitter:


    Pinterest: https://www.pinterest.com/easymedicaldevice Instagram:

    • 28 min
    Medical Device News - June 2022 Regulatory Update

    Medical Device News - June 2022 Regulatory Update

     

    Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes. 

    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 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, podcasts, online courses... 

    Links

    NEWS

    - Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf

    - Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html

    ○ Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr

    - Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html

    ○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

    - EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf - EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729

    - EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757

    - Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894

    - Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/

    - Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/

    NOTIFIED BODY

    - 3EC International - IVDR 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

    - TÜV Nord - EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8

    - Berlin Cert - EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955

    - Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf

    GUIDANCE

    - MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf

    - MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf

    - MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf

    - MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf

    - MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf

    PODCAST

    - Episode 179 - How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/

    - Episode 180 - What happens after the IVDR Date of Application with Colm O'Rourke: https://podcast.easymedicaldevice.com/180/

    - Episode 181 - What to learn about the EU M

    Let's introduce our eQMS Smarteye with Anindya Mookerjea

    Let's introduce our eQMS Smarteye with Anindya Mookerjea

    Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invited Anindya Mookerjea the CEO of SCube Technologies. We will talk about eQMS solutions and how the idea of SmartEye came. I was part of the development of certain modules and this is really satisfying to see that auditors or customers like them. Don’t forget to ask for a demo.

    Who is Anindya Mookerjea?

    Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product.

    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 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, podcasts, online courses…

    Links

    Anindya Mookerjea Linkedin Profile: https://www.linkedin.com/in/anindya-mookerjea-6b5367209/

    SCube Technologies website: https://scube-technologies.com/

    SCube Technologies Linkedin Page: https://www.linkedin.com/company/scube-technologies/

    Twitter account: https://twitter.com/scubetechno

    Facebook account: https://www.facebook.com/i.scubetechnologies

    Article Medical Device development: https://easymedicaldevice.com/medical-device-development/

    What is the EU Medical Device Situation? with Erik Vollebregt

    What is the EU Medical Device Situation? with Erik Vollebregt

    The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to summarize the discussions that happened. The topics that we will cover are:

    Health Technology Assessment (HTA)

    Digitalization for Medical Devices post-Covid

    EU Commission not providing all the answers

    Centralization for Medical Devices like FDA or EMA

    Extension of EU MDR

    Legacy devices versus New devices

    New technologies pathway

    EU Market versus US Market



    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, and 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 in 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 specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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, podcasts, online courses...

    Links 

    Medtech Europe: https://www.medtecheurope.org/

    Erik Vollebregt profile: https://www.linkedin.com/in/erikvollebregt/

    Axon lawyers: https://www.axonlawyers.com/

    HTA EU Commission: https://ec.europa.eu/health/health-technology-assessment/overview_en

    Podcast episode 173 - EU MDR extension: https://podcast.easymedicaldevice.com/173/



     

    • 26 min

Customer Reviews

4.8 out of 5
6 Ratings

6 Ratings

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