Medical Device made Easy Podcast

easymedicaldevice
Medical Device made Easy Podcast

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.

  1. The good, the bad and the ugly of certification bodies

    4 DAYS AGO

    The good, the bad and the ugly of certification bodies

    In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good.  Who is Mark Rogovoi?  Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master's degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University.  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 Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/  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

    37 min
  2. Medical Device News January 2025 Regulatory Update

    6 FEB

    Medical Device News January 2025 Regulatory Update

    Medboard EU EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type   TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems   UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

    28 min
  3. 6 Tips to Grow as a QA RA Manager 

    30 JAN

    6 Tips to Grow as a QA RA Manager 

    In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic.  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.  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

    30 min
  4. TOP 5 common NCs on an ISO 13485 audit 

    23 JAN

    TOP 5 common NCs on an ISO 13485 audit 

    In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you.  Who is Adam Isaacs 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 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 Adam Isaacs Rae LinkedIn:  https://www.linkedin.com/in/adam-isaacs-rae/ Top ISO 13485 Nonconformances: https://easymedicaldevice.com/top-iso-13485-nonconformances-and-how-to-prevent-them/ 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

    51 min
  5. How to perform your PMS for a Drug-Device Combination?

    16 JAN

    How to perform your PMS for a Drug-Device Combination?

    In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow.  Who is Joan D’Souza?  I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion for learning, and a longstanding insight into the pharmaceutical sector. I am driven, hard-working, enthusiastic, and always willing to take on new responsibilities. Therapeutic areas: vaccines, endocrinology, immunology, rare diseases, gastroenterology, autoimmune diseases, cardiovascular diseases, dermatology, medical devices, drug-device combinations, oncology, and neurology. 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 Joana de Souza LinkedIn:  https://www.linkedin.com/in/drjoanswatidsouza/ 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

    20 min
  6. How to register a Medical Device in South Africa? 

    9 JAN

    How to register a Medical Device in South Africa? 

    In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where  pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.  Who is Khanyisile Nkuku?  Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration  Officer  at the South Africa Competent Authority (SAHPRA) ,  she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa  to promote medical device & IVD access on a global scale, with a particular focus on African countries. She holds a Bachelor of Pharmacy  honours degree ,a Master’s in Pharmacy administration & Policy Regulation ,  and is currently busy with Masters in Business Administration in Healthcare Leadership . She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance. She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF)  technical mainly the MDA-TC ( Medical device Assessment Technical committee  member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees . 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 Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9 SAHPRA Website: https://www.sahpra.org.za/medical-devices/ 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

    35 min
  7. Easy Medical Device Great Summary 2024

    26/12/2024

    Easy Medical Device Great Summary 2024

    In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025.  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.   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

    31 min

Ratings & Reviews

4.8
out of 5
9 Ratings

About

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.

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