Easy Medical Device Podcast

Easy Medical Device Podcast

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Easy Medical Device Podcast episodes

  • The good, bad and uglyof using AIfor QA RA Compliance

    Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance?

    In this new episode of the Medical Device Made Easy Podcast, Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of using AI in regulatory compliance. Together, they discuss:

    Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok

    How to integrate AI into different product design and regulatory phases

    The role of Prompt Engineering and why it matters in compliance

    Practical tips for creating effective AI prompts

    The warnings and risks you should keep in mind when relying on AI

    How agencies like the FDA are beginning to explore AI for dossier reviews

    👉 If you want to stay ahead in the world of medical device compliance, this conversation is a must-li

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

    35 min
  • Medical Device Software Versioning

    Managing Software Updates in Medical Devices: Best Practices & Pitfalls

    In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304.

    In this episode of our podcast, we dive into the critical aspects of software update management for medical devices:

    Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments.

    Documentation & traceability – Why proper version control and documentation are essential for audits and compliance.

    Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams.

    Common pitfalls – Mistakes that lead to compliance risks and how to avoid them.

    Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy.

    Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process.

    👉 Listen now and discover how to master the balance between innovation, safety, and compliance in medical device software.

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

    40 min
  • From Zero to One How to collaborate with clients

    From Zero to One: Mastering Client Collaboration in Consulting
    Starting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical Device Made Easy podcast, I share my personal path: from my early days in engineering to creating Simply Medica, and the lessons learned along the way.
    We discuss how to:

    Build credibility before calling yourself a consultant

    Turn your first project into a stream of referrals

    Use networking (both in-person and online) to grow

    Balance expertise with passion to create real impact
    For anyone starting out—or looking to strengthen client relationships—this is your roadmap from zero to one.

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

    41 min
  • From Zero to One: Becoming a Medical Device auditor

    Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world.

    Adam’s journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising.

    What you’ll discover in this episode:

    📈 How Adam transitioned into RAQA with no previous background

    ✅ The real day-to-day life of an ISO 13485 auditor — separating myths from reality

    ⚠️ Common mistakes consultants and auditors should avoid

    🤝 What clients truly value when hiring a consultant

    🚀 How to grow your consulting business organically

    🤖 Adam’s next big step: creating an AI-powered audit tool to transform compliance work

    Whether you’re just starting your career in medical devices or thinking about launching your own consultancy, this episode offers honest, practical insights you won’t find in any textbook.

    🎧 Listen now and gain a realistic perspective on what it takes to succeed in the highly regulated MedTech industry.

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

    58 min
  • From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode

    In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you're a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice.

    What you’ll learn:

    Why Mitch chose to specialize in QA/RA

    The tension between client expectations and candidate realities

    How recruiters make their revenue (yes, we ask the money question!)

    Whether promoting open positions is still a challenge in 2025

    Mitch’s personal journey—education, family, and the struggles of building a business from scratch

    What he would do differently if he had to start again

    Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one."

    👉 Listen now and subscribe to our podcast to never miss a new episode!

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

    Website: https://theanthonymichaelgroup.com/

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

    49 min
  • Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers

    Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices

    On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI.

    This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU.

    🔎 What the regulation says:

    Manufacturers are allowed to provide eIFUs for professional-use devices, as long as the device is not likely to be used by laypersons.

    For any device that might be used at home or by a non-professional, a paper IFU is still mandatory.

    All versions of an eIFU—current and obsolete—must be hosted securely and remain accessible to authorities on request.

    The URL of the eIFU must be registered in EUDAMED's UDI database once that requirement becomes mandatory.

    📌 Top 5 reasons why switching to eIFU makes sense:

    Broader regulatory permission
    This update grants manufacturers the freedom to digitize IFUs across their entire product line, simplifying regulatory planning and execution.

    Significant cost savings and faster updates
    With eIFUs, there’s no need for printing, translation management across packaging batches, or physical distribution—everything can be updated instantly online, cutting costs and time-to-market.

    Improved traceability and audit readiness
    Digitally managing eIFUs ensures version control, easy access for auditors, and a clean digital trail that supports internal QA systems.

    Better experience for healthcare professionals
    Healthcare professionals prefer electronic formats for their speed, searchability, and multilingual options—making your devices more user-friendly.

    Alignment with the EU’s digital vision
    By linking eIFUs directly with EUDAMED and UDI databases, you align your business with the evolving regulatory ecosystem and future-proof your documentation process.

    🛑 But eIFU is not a one-size-fits-all solution. You still need paper IFUs in key scenarios:

    If your device could be used by laypersons, you must provide a paper version.

    In low-connectivity settings, such as field hospitals or rural clinics, physical IFUs may be more reliable.

    Adopting eIFU requires full platform readiness, including hosting, backups, multilingual versions, and internal QA validation.

    Regulatory responsibility is now entirely on the manufacturer—including website uptime, version archives, and EUDAMED linkage.

    Some stakeholders—including auditors and hospitals—still prefer traditional paper documentation, which could delay full adoption.

    📽️ Watch our video to get a complete overview of the regulation and see how EasyIFU helps you implement a compliant, secure, and future-ready eIFU process. This is essential for RA/QA teams, product managers, and any manufacturer operating under MDR.

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

    31 min
  • Quality & Regulatory in MedTech – Interview with Pardeep Kaur

     

    Background: From IT in India to MedTech in Norway 

    You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?) 

    What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon? 

    And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?) 

    Day-to-Day as a QARA Manager  

    Let’s talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?) 

    It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine? 

    We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic? 

    On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding? 

    (For example, is it challenging that the scope is so broad – one moment you’re deep in engineering specs, next moment you’re updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?) 

    First MedTech Role at Hy5Pro AS 

    Let’s dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands? 

    (Feel free to explain what Hy5Pro’s product was and your role there, e.g. implementing the quality system, getting certifications, etc.) 

    Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that? 

    (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.) 

    Leading QARA at RemovAid AS  

    After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role? 

    RemovAid’s product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale. 

    (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!) 

    On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)? 

    RemovAid is in women’s health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it’s about making contraceptive care easier – that’s quite impactful.) 

    Consulting Experience at LINK Medical  

    Now, currently you’re working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company? 

    I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company’s project mid-stream. 

    Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you’ve learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)* 

    Diversity and International Career Insights  

    I’d like to touch on diversity and your international experience. You’re a woman in the medtech industry and you’ve built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you’ve noticed working in Norway compared to India? 

    The medtech industry, especially in leadership, still isn’t very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career? 

    What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.) 

    Rapid-Fire Round  

    Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I’ll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go! 

    Question 1: What’s one thing about your job that most people would be surprised to learn? 

    Question 2: What’s the coolest medical device or gadget you’ve worked on or seen so far? 

    Question 3: Are you team coffee or tea? (What fuels your workdays?) 

    Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)? 

    Question 5: If you weren’t in QARA, what alternate career could you see yourself in? 

    Question 6: What’s one Norwegian word or phrase you’ve picked up that you love to use? (Bonus: translate it for us!)* 

    Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!) 

    (Guest gives rapid-fire answers with laughter and brief commentary.) 

    Advice and Closing  

    Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect? 

    (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.) 

    And maybe equally important, what should they not be scared of? People might think “Oh, I’m not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation? 

     

     

    Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital) 

    Welcome & Setup 

    Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager? 

    Career Journey 

    How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway? 

    What motivated you to switch into medical device regulations, and what were the biggest initial challenges? 

    In what ways has your IT background helped you excel in QARA? 

    Day-to-Day Responsibilities 

    What does a typical day or week look like for you as a QARA Manager? 

    Which tools or software (QMS systems, document controls, etc.) do you rely on most? 

    Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it’s all paperwork? 

    Which aspects of QARA do you find most challenging, and which are the most rewarding? 

    Hy5Pro AS Experience 

    What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand? 

    Can you share a memorable “learning moment” or funny anecdote from your time there? 

    RemovAid AS Experience 

    At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities? 

    Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it. 

    Any unexpected or humorous challenges you overcame in that role? 

    How did working on a women’s health product impact you personally? 

    LINK Medical Consulting 

    How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions? 

    What’s a standout project or recurring compliance issue you help clients solve? 

    How do you stay organized when juggling multiple clients and deadlines? 

    Diversity & International Insights 

    As a woman in medtech QARA, have you faced any unique challenges or opportunities? 

    What cultural adjustments did you experience moving from India to Norway? 

    How can medtech teams become more inclusive, especially in QA/RA? 

    Rapid-Fire Round 
    (Answer quickly with the first thing that comes to mind.) 

    One surprise fact about your job? 

    Coolest device or gadget you’ve worked on or seen? 

    Favorite (or funniest) QARA acronym—what does it mean? 

    Alternate career you might have chosen? 

    Norwegian word or phrase you love—translate it for us! 

    If your career were a movie title, what would it be? 

    Closing Advice 

    What practical steps should students or career-changers take to break into QARA? 

    What misconceptions shouldn’t they be afraid of when considering this field? 

     

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

    50 min
  • From Zero to One: Creating your Consulting Firm

    Guest: Stefan Bolleininger 

    Title: From Zero to One: Creating your Consulting Firm 

    Logo: Be on Quality  

    Telling the story behind Be on Quality,  

    the challenges for you,  

    the way you did grow the business,  

    the things you would do differently  

    cost 

    Sharing also the life of a CEO that did start this project.  

    How many hours are you working,  

    is it easy to disconnect,  

    what are your fears....   AI 

    What’s next for Be on Quality 

     

    Link: 

    Be on Quality:  https://www.be-on-quality.com/

    Stefan Bolleininger Linkedin:  https://www.linkedin.com/in/stefan-bolleininger-3a717028/

    Quick recap 

    Stefan shared his entrepreneurial journey from working in automotive quality management to founding and growing his medical device consulting company, which was later acquired by a French engineering firm and merged with his sister company in Switzerland. Through discussions with Monir about his business experiences, they explored topics including customer relationships, pricing strategies, and the challenges of managing company growth while maintaining quality and communication. Stefan emphasized the importance of taking risks, maintaining industry connections, and leveraging technology while emphasizing the value of human interaction in their field, particularly in the context of his company's recent acquisition and expansion. 

    Next steps 

    Stefan to continue leading Be on Quality through the merger with Volker group. 

    Be on Quality team to expand services, particularly in AI implementation for medical devices and clinical trial areas. 

    Stefan to maintain transparent communication with employees regarding company changes and future plans. 

    Be on Quality to collaborate with sister company Be on Conception in Switzerland on combination products. 

    Stefan to continue balancing work responsibilities with personal time, including occasional “beach visits”. 

    Stefan to maintain regular revenue and project load calculations to mitigate fears about project availability. 

    Stefan to focus on providing value and mentorship to senior consultants and business area leads. 

    Be on Quality team to continue using AI as a tool to enhance work efficiency without replacing human expertise. 

    Summary 

    Journey to Medical Device Consulting 

    Stefan shared his journey from working in automotive quality management to founding his own medical device consulting company, Be on Quality GmbH, after being encouraged by his mentor. He described how he grew the business through referrals and local connections in Nuremberg, where there are approximately 500 medical device companies. Stefan emphasized that taking risks is essential for growth, particularly when transitioning from freelance work to company ownership, and noted that his supportive wife's encouragement was crucial since he was the first entrepreneur in his family. 

    Customer Retention Strategies in Medical Devices 

    Stefan emphasized the importance of maintaining connections and visibility in their industry, highlighting that cold calling and direct knocking do not work effectively. He shared experiences of past customer relationships, including a challenging project where deliverables did not meet the client's expectations, leading to a contract that could not be salvaged. Stefan stressed the need for clear communication and alignment with customer expectations to ensure long-term customer retention, which is crucial in their competitive medical device regulatory market. Monir suggested a mechanism for filtering potential customers with a small initial project to assess compatibility and expectations, which Stefan acknowledged as a useful approach, especially for startups and small companies. 

    Business Growth and Team Dynamics 

    Stefan discussed his business challenges, including a difficult working relationship with a former colleague that led to a split, but emphasized that such challenges are part of growing a company. He reflected on how his company, which started in 2017 and began as a freelance business in 2013, has grown to 27 employees, with his team sometimes advising him to focus on organic growth rather than taking on new projects. Stefan noted that while MDR hasn't significantly accelerated his business, he finds working with technology and engineering companies most comfortable, though his team has expertise across various product types. 

    Client Pricing and Documentation Insights 

    Stefan and Monir discussed pricing challenges with clients, where Stefan noted that while some clients negotiate prices, none have shown negative emotions about pricing. They also discussed the high costs of notified bodies and the importance of creating high-quality technical documentation to reduce review rounds. Stefan shared his perspective as CEO of Be on Quality, revealing he works approximately 50 hours per week and enjoys his job, though he prefers the concept of office time and home time rather than work-life balance. 

    AI's Role in Human Work 

    Stefan shared his professional journey, particularly in housing and installation projects, and expressed concerns about the evolving nature of his role as the company grows. He acknowledged his fear of not being able to provide sufficient mentoring to his colleagues, despite his efforts to maintain a hands-on approach. Stefan also discussed his perspective on artificial intelligence, emphasizing its potential to enhance rather than replace human work, and highlighted the importance of human interaction in their industry. Monir encouraged Stefan to view AI as a tool to assist and inspire, rather than relying on it systematically for all tasks. 

    Strategic Company Acquisition Success 

    Stefan discussed the recent acquisition of his company by a larger partner, which he described as a strategic move to expand services and reach. He emphasized that the decision was made after thorough discussions with his team, who supported the merger despite initial concerns about changes. Stefan highlighted the importance of trust and open communication within the company, which he believes contributed to the successful transition. The acquisition has allowed his company to grow and make a bigger impact, with additional resources and expertise from the partner company. 

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

    1 hr 3 min
  • Medical Device News JULY 2025 Regulatory Update

    Medboard: https://www.medboard.com/

    EUROPE

    new eIFU rules - Let's save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj

    https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en

    EasyIFU.com

     

    MDR + IVDR + AI Act = MDCG 2025-6 - Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf

    MDCG 2025-5: IVDR Performance Study - Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf

    Team-NB. Software Qualification (IVDR) clarification - Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf

    MDCG 2019-11: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf

     

    CECP: Mechanical Respiratory - Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf

    MDCG 2025-4 Software delivered with Online Platforms - Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf

    PROJECT NAME: COMBINE - Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447

    https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en

    UK

    UK PMS mandatory since June 16th, 2025 - Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history

    Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain

    Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur

    Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents

    MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf

    Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations

     

    ROW

    USA

    UDI for combination products - What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-productsConducting Remote Reg Assessment - SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers

     Transfer of Premarket Notification (510k) - Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers

     

    CANADA

    Canada is cancelling all MDELs - Only if you don't confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html

     

    Saudi Arabia

    SFDA Webinar: Risk Management File - July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398

    Podcast

    Episode 340 - Software as a Medical Device: Beginner's guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/

    Episode 341 - Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/

    Episode 342: From Zero to One: SaaS Founder's First Five Years: https://podcast.easymedicaldevice.com/342-2/

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

    33 min
  • From Zero to One: SaaS Founder's First Five Years

    From Zero to One: SaaS Founder's First Five Years with Ivan Perez Chamorro 🎧💡

    In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the CEO and founder of Medboard, a fast-growing SaaS company. Ivan takes us behind the scenes of his entrepreneurial journey, from starting with zero to building a thriving business in the tech world. 🚀

    In this candid conversation, Ivan dives into:

    The story behind Medboard and how it all began from scratch 🛠️

    The challenges he faced along the way and how he successfully scaled the business 📈

    The lessons learned and the things he would do differently if given a second chance 🤔

    A day in the life of a CEO: How many hours does Ivan work? How does he disconnect? 🤯

    The personal fears and struggles that come with being a founder, and how to overcome them 😬

    And of course, what’s next for Medboard—the exciting plans ahead! 🔮

    This episode offers an honest, no-holds-barred look at the journey of building a successful SaaS company and what it takes to lead with passion, persistence, and resilience.

    Don't miss this insightful discussion! Tune in now and hear firsthand what it takes to take a business from zero to one.

    Listen to the full episode here: Medboard

    Social Media to follow

    ivan-perez-chamorro linkedin: https://www.linkedin.com/in/ivan-perez-chamorro/

    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.

    1 hr 4 min

About Easy Medical Device Podcast

From the publisher's feed

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…

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