Episodios

  • Medical Device News APRIL 2026 Regulatory Update

    Medical Device News APRIL 2026 Regulatory Update
    Apr 1 2026
    MedboardSponsor: Medboard: https://www.medboard.com/ EUExtension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809Update your MIR form - Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf UKFuture Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulationsConsultation on indefinite recognition of CE marked medical devices and current transitional arrangementsPre-market Statutory Instrument (SI)Future Enhancemens: Exceptional Use Authorization and Health Institution exemptionPost-market Surveillance RequirementsUpdate to guidances Learn Clinical Investigation in the UK - Lot of questions answered: Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devicesClinical investigations: investigators' responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigatorsClinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerationsMedical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigationDetermining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-requiredClinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png EventsTeam NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdfEgypt: Vigilance reporting Training - April 7 to 9, 2026: https://tinyurl.com/emdpodcastMedtechConf.com - Check the MAPEUSwiss Medtech Day 2026 - June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/Medtech Forum - May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/USVeeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/BrazilHospitalar - May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/ RoWAustralia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australiaYour advertisement must contain:an accurate description of the devicethe trade name of the devicethe intended purpose(s) of the deviceany mandatory statements and, where relevant, health warnings.For example, you must not:claim your product is “TGA approved”make unsubstantiated claims about the product’s performanceinclude endorsements or testimonials from health professionals or medical researchers.Malaysia: Guidance Creation/Update - Medical Device Act 2012 Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devicesGuidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devicesGuidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-applicationIndia: FAQ on IVD products - 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdfEgypt: What you need to register - List of documents: https://tinyurl.com/EmdEgyptRegistration PodcastPodcast Nostalgia -Let's remember: https://podcast.easymedicaldevice.com/Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/ ServiceNew Website: https://easymedicaldevice.comAuthorized RepresentativeConsultingTrainingEasyIFU: https://easyifu.comSmarteye: https://eqms-smarteye.com/ This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    28 m
  • These 3 podcasts will change how you see MedTech

    These 3 podcasts will change how you see MedTech
    Mar 26 2026

    The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.
    To help you stay ahead, we’ve gathered the most valuable insights from three MedTech podcasts into one concise summary.

    In this article/video, we explore:

    Key regulatory challenges related to FDA and MDR

    Common mistakes that delay device approval

    Strategic advice from industry experts

    These insights highlight one essential truth: success in MedTech is not only about innovation, but also about understanding regulatory pathways and execution.

    Whether you are a startup founder, regulatory professional, or industry enthusiast, these lessons will help

    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 powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    16 m
  • EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare

    EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
    Mar 19 2026

    The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.

    While many companies believe this transition is simply about uploading documents into a European database, the reality is far more complex.

    EUDAMED is not just a database — it is becoming the central regulatory infrastructure of the European medical device ecosystem, connecting manufacturers, notified bodies, regulators, and economic operators.

    Why EUDAMED Matters

    EUDAMED aims to increase:
    • Transparency
    • Traceability
    • Post-market surveillance
    • Regulatory oversight

    To achieve this, companies must ensure that their internal data is structured, accurate, and aligned with regulatory expectations.

    The Biggest Mistake

    The most common misconception is treating EUDAMED as an IT project.

    In reality, it is a data governance challenge.

    Before uploading any device, companies must clearly define:
    • Device families
    • Basic UDI-DI and UDI-DI
    • Certificate linkage
    • Legal manufacturer responsibilities

    Many organizations struggle with these fundamentals.

    The 7-Step Readiness Checklist

    To prepare effectively, QA/RA teams should focus on:

    Actor registration (SRN)

    Cleaning the device portfolio

    Validating the UDI structure

    Checking certificate data

    Defining legacy device strategy

    Assigning data ownership

    Performing a dry run

    Risks of Delayed Preparation

    Companies that delay preparation may face:
    • Incomplete or inconsistent data
    • Registration delays
    • Regulatory bottlenecks
    • Internal confusion

    EUDAMED could quickly become a regulatory traffic jam for unprepared organizations.

    A Practical Timeline

    To avoid these risks:

    • Immediately: Audit all regulatory data
    • Next 1–2 months: Validate UDI structure and device hierarchy
    • Before the deadline: Perform a full readiness simulation

    Final Takeaway

    EUDAMED is not just a compliance requirement — it is a transformation of how regulatory information is managed in Europe.

    Companies that prepare early will transition smoothly.
    Those that wait may face significant delays and operational challenges.

    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 powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    10 m
  • Medical Device News March 2026 Regulatory Update

    Medical Device News March 2026 Regulatory Update
    Mar 13 2026
    MedboardSponsor: Medboard: https://www.medboard.com/EuropePharmacist are distributors - French guide issued to educate them: https://medboard-public-assets.s3.amazonaws.com/Regulatory/9b892d08-611c-4326-a40e-750e0364df27.pdfTeam NBTeam NB position Paper - Reduced Scrutiny, Cost saving: https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdfTeam-NB Demonstrate Safety and performance - For Combination of reagent and other equipment: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdfTeam-NB- Letter on Cybersecurity - New Proposal again: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfTeam-NB - MDR Clinical & Tech File Training - Check the dates: https://medboard-public-assets.s3.amazonaws.com/Regulatory/442102-Leaflet-MDR-Clinical-Manufacturers-Training-20260528.pdf and https://www.team-nb.org/wp-content/uploads/2026/02/Leaflet-MDR-TD-Manufacturers-Training-20260429.pdfUKConsultation on recognizing CE mark - Should it be indefinitely: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devicesConsultation until: April 10, 2026 UK Reliance is ongoing - Draft proposal to recognize MDSAP and other: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devicesBookmark the MHRA contact page -*Whispering* If you want to Whistleblow, there is a contact Chuuut!!!: https://www.gov.uk/guidance/contact-mhraSolutionsEasyIFU: For eifu and Label - Test it for Free: https://easyifu.comSmarteye: for eQMS . Ask for a Demo: https://eqms-smarteye.com/RoWIMDRFReliance Playbook - With examples to apply: https://www.imdrf.org/sites/default/files/2026-02/IMDRF%20GRRP%20WG%20N89%20Reliance%20Playbook.pdfUSAFDA Cybersecurity documentation - Final Guidance: https://www.fda.gov/media/119933/downloadMalaysiaLaunch of the Innovative Pathway - Accelerate the development of your device: https://portal.mda.gov.my/index.php/announcement/1771-implementation-of-the-innovative-medical-device-review-pathway-by-medical-device-authority-ministry-of-health-malaysiaArgentinaSelf Declaration expended for Low-Risk devices - Themis platform to be used: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos PodcastEpisode 376 - Defect Management in SaMD with Anindya Mookerjea: https://podcast.easymedicaldevice.com/376-2/Episode 377 - IEC 60601 4th edition with Leo Eisner: https://podcast.easymedicaldevice.com/377-2/Episode 378 - IMDRF & Regulatory Reliance with Stephanie Grassmann: https://podcast.easymedicaldevice.com/378-2/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    33 m
  • IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals

    IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
    Mar 5 2026
    The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient access to life-saving technologies.To address this challenge, international regulators are increasingly collaborating through the International Medical Device Regulators Forum (IMDRF).In this podcast episode, Stephanie Grassmann (MedTechXperts) joins us to discuss how the concept of Regulatory Reliance is transforming global medical device approvals.What is IMDRF?The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulatory authorities working together to harmonize medical device regulations and reduce duplication across global markets.Members include major regulatory bodies such as:• United States (FDA)• European Union• Australia (TGA)• Brazil (ANVISA)• Canada (Health Canada)• China (NMPA)Their mission is to promote efficient regulation while maintaining high standards of safety and performance.Understanding Regulatory RelianceRegulatory reliance allows one authority to give significant weight to the work already performed by another trusted regulator.Instead of repeating full assessments, authorities can leverage existing evaluations, reducing regulatory burden while maintaining confidence in safety and effectiveness.Real-World Success StoriesSeveral regulators are already demonstrating the benefits of reliance mechanisms.Australia – TGAA Class III Mitral Valve Clip reached market access in just 20 working days after the regulator accepted evidence generated overseas.Argentina – ANMATDental instruments known as endodontic barbed broaches were approved in 9 working days using reliance pathways.Brazil – ANVISACompanies holding MDSAP certification may skip immediate on-site audits, saving both time and money during market entry.These examples show how regulatory cooperation can significantly accelerate approvals.The Role of MDSAPThe Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit recognized by multiple countries.This program plays a key role in enabling reliance between regulatory authorities and reducing redundant inspections.The European PerspectiveEurope has historically maintained a distinct regulatory framework under EU MDR and IVDR.However, recent proposals—including references to Articles 108a and 108b—suggest increasing collaboration with international frameworks such as IMDRF and MDSAP.While a single global approval system remains a long-term goal, reliance initiatives are already demonstrating that cooperation between regulators can improve efficiency without compromising safety.Looking AheadFor manufacturers and startups, embracing international regulatory frameworks early—such as MDSAP and IMDRF guidance—can significantly improve global market access strategies.As regulatory collaboration grows, the future of medical device approvals may become faster, more harmonized, and more patient-centered.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkStephanie Grassmann Linkedin: https://www.linkedin.com/in/stephaniegrassmann-medtechxperts/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    38 m
  • IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know

    IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
    Feb 26 2026

    IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the standard has continuously evolved to address technological and regulatory complexity.

    Now, the upcoming 4th edition represents more than an amendment — it signals a structural transformation.

    This article explores:

    The Evolution of IEC 60601

    • Key shifts from the 2nd to the 3rd edition
    • Why risk management became central
    • What lessons shaped today’s safety philosophy

    What the 4th Edition Brings

    • A major rewrite rather than incremental updates
    • The introduction of “atomic requirements”
    • Structural clarity for manufacturers, test labs, and regulators
    • Emerging technical considerations (digitalization, AI, cybersecurity, home use)

    Impact on Existing Devices

    • Will re-testing be required?
    • How to assess validity of existing test reports
    • Transition strategies with notified bodies

    Integration into Design & Documentation

    • Embedding IEC 60601 into risk management from day one
    • Required updates in risk files, EMC documentation, labeling, and usability engineering
    • Practical advice for SMEs with limited resources

    The Future of IEC 60601

    • Greater harmonization with ISO 14971 and IEC 62304
    • Alignment with digital and AI regulatory frameworks
    • The long-term outlook for medical electrical safety

    For manufacturers, the message is clear:
    IEC 60601 is not just a testing standard — it is a design and risk management framework that must be integrated early and strategically.

    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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

    If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

    Link

    Leo Linkedin: https://www.linkedin.com/in/leoeisnersafetyconsultants/

    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 powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    39 m
  • Defect Management in SaMD — From Chaos to Control

    Defect Management in SaMD — From Chaos to Control
    Feb 19 2026

    In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.

    This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.

    We cover:

    Understanding Defects in SaMD

    • What defines a defect in a regulated context
    • How defect management differs from non-medical software
    • The relationship between defects, risk management, and ISO 14971

    Building a Compliant Defect Management Process

    • Essential documentation and tools
    • Severity and priority categorization
    • Handling defects discovered during validation or post-market
    • Differentiating between defects, change requests, and requirement gaps

    Advanced & Real-World Scenarios

    • Managing safety-critical defects
    • When CAPA or vigilance reporting is required
    • Handling SOUP and third-party component issues
    • Ensuring traceability across versions and product variants
    • Agile defect management strategies

    Audit Perspective & Common Pitfalls

    • Frequent gaps identified by regulators and notified bodies
    • How defect trend data supports CAPA and management review
    • Practical advice for startups implementing lightweight but compliant systems

    We also discuss how modern eQMS platforms (such as SmartEye) can help streamline documentation, automate traceability, and improve oversight without adding unnecessary bureaucracy.

    Defect management in SaMD is not about documentation — it’s about maintaining control over risk and ensuring safe, effective software throughout its lifecycle.

    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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

    If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

    Link

    Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/

    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 powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    46 m
  • Medical Device News February 2026 Regulatory Update

    Medical Device News February 2026 Regulatory Update
    Feb 11 2026
    SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards - Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026 High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
    Más Menos
    34 m