The Being An Engineer podcast is a central repository in which we collect and share industry knowledge & best practices associated with the discipline of engineering. We hope that engineers throughout the world will benefit from this content as they connect with the companies, technologies, people, resources, and opportunities that are relevant to their engineering or engineering-adjacent roles. Contact us at [email protected]. Intro and Outro music by John Martell
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Medical Device Engineering Podcasts
Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other ...
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Welcome to life at the USC Viterbi School of Engineering. Classes, student organizations, faculty, research, hands-on projects, and don't forget our social lives outside of class - it's all up for discussion with regular appearances and interviews with special guests. Viterbi Voices: The Podcast is hosted by Paul Ledesma (Executive Director, Undergraduate Admission) and current student Hannah Fonseca (Mechanical Engineering, Class of 2027).
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Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.
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The Medical Devices Group is the medical device industry hub that connects you with experts cherry-picked among our 350,000 members. • MedicalDevicesGroup.net – 1,000+ archived discussions + resources • medgroup.biz/premium – direct access to medical device experts • medgroup.biz/10x – in-person events • medgroup.biz/linkedin – legacy group • medgroup.biz/podcast – this podcast • medgroup.biz/eavesdrop – sister podcast Medical device work saves and transform lives, so we make our recordings, ...
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A regular series of views, opinions and commentary from the international association for the engineering modelling, analysis and simulation community.
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Welcome to the U-Squared podcast! ”A discussion of the exponential benefit of “useful usability.” This podcast is all about Human Factors in the Medical Device industry. In each episode, we’ll explore different facets of Human Factors Engineering.
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The PCB Design Podcast features conversations on all facets of PCB Design and Hardware Development
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Learn how to break into cybersecurity, build new skills and move up the career ladder. Each week on the Cyber Work Podcast, host Chris Sienko sits down with thought leaders from Carbon Black, IBM, CompTIA and others to discuss the latest cybersecurity workforce trends.
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The Association for the Advancement of Medical Instrumentation Podcast - AAMI
Association for the Advancement of Medical Instrumentation
The Association for the Advancement of Medical Instrumentation (AAMI) is developing a series of podcasts in partnership with the studios of Healthcare Tech Talk. The podcasts will explore today's most pressing healthcare technology challenges and the multidisciplinary approaches that are being used to clarify and resolve them. Terry Baker and Kelley Hill, along with renowned subject matter experts, discuss everything from how different technology is developed, implemented, used and maintaine ...
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The AWS Health Innovation Podcast showcases entrepreneurs and investors who are driving progress in healthcare and life science across the globe.
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‘Understanding IP Matters,’ is a popular podcast series that enables successful entrepreneurs, inventors, content creators, executives and experts to share their IP story - the good, bad and amazing. The series is brought to you by the Center for Intellectual Property Understanding, an independent non-profit established in 2016. CIPU provides outreach to improve IP awareness, enhance value and promote sharing. www.understandingip.org
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Digital Engineering 24/7 is your source for unique engineering technology news and information for Engineering Design, Simulation, Prototyping, Testing and Computing. Our engineering community podcast will bring you content about CAD, CAM, FEA, 3D-Printing, technology and more.
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Cancer saved my life. Sometimes the worst news can make you look at life in a whole new way. I've been both a caregiver and now a survivor, actually an outlier, having beaten one of the deadliest cancers, so I'm here to provide hope and inspiration to all of you. We'll talk to experts, share survivor stories, reflect on the meaning of life...and have fun doing it!
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Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doc ...
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Technology tips and insights to help protect your business! We offer weekly interviews with industry experts and leaders from companies like Coca-Cola, Verizon and AT&T to share their insights on cybersecurity and other technology topics. Join your host, Shaun St.Hill, the CEO of Tech and Main!
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Cadaver Labs, Medical Devices, and Marketing with Pooja Sharma Rao, B.S. Biomedical Engineering (Biochemical) '07
1:25:32
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1:25:32In this episode, Paul sits down with Viterbi alumna Pooja Sharma Rao to talk about her unique career journey at the intersection of medicine, engineering, and business. From hands-on experiences in cadaver labs to developing and marketing medical devices, Pooja shares how her time at USC prepared her for a dynamic career in the healthcare industry.…
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The Human Factor: A Practical Guide to IEC 62366-1 Usability Engineering
3:21
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3:21This episode demystifies the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices. We explore how this process-oriented standard is critical not just for user satisfaction, but for ensuring patient safety by minimizing use-related risks. Learn about the key phases, from defining us…
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Celebrated MIT engineer and entrepreneur develops medical devices to treat cancer and other diseases
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42:22Send us a text Michael Cima is a researcher, inventor and entrepreneur who has spent 40-years creating advanced medical devices that focus on diagnostics and treatments for cancer, metabolic diseases and trauma. He is also devoted educator mentoring the next generation of creators about the broad benefits of IP rights.…
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Unlocking Global Markets with the New Health Software Security Standard
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3:09This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why comp…
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One Audit, Five Markets: Unlocking Global Access with MDSAP
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2:50This episode demystifies the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements of five different countries. We explore its history, the participating authorities, the benefits for manufacturers—including reduced audit fatigue and faster market access—and how the program streamlin…
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S6E31 Camden Shuman | Building a Second Brain, Co-ops, & Tools for Developing Your Network
45:12
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45:12Send us a text In this episode, Camden Shuman discusses his experiences as a co-op student at Siemens Healthineers, where he has gained valuable hands-on experience in mechanical design work. He also shares insights about his entrepreneurial venture, "The Engineering Way" newsletter, which aims to help engineering students and professionals develop…
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18-Year-Old Founder: Why America Needs Its Own Drone Industry
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36:32Meet Tom Rein, the youngest entrepreneur ever featured on the Altium OnTrack podcast and founder of Tom's Aerial Vehicles. At just 18 years old, Tom is revolutionizing American drone manufacturing with AI-powered development processes and proprietary hardware designs. In this compelling interview, discover how this young innovator is building polic…
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From FDA Clearance to TGA Inclusion: Navigating the Australian Medical Device Market
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3:26This episode details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therapeutic Goods (ARTG). We explore how leveraging your existing FDA approval can streamline the TGA inclusion process, the critical role of an Australian Sponsor, and the importance of recent regulatory up…
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Inside PCBAA's Fight for American Circuit Board Manufacturing
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38:41Join host Zach Peterson as he sits down with David Schild, Executive Director of the Printed Circuit Board Association of America (PCBAA), fresh from their annual Washington D.C. meeting. Discover how the organization is advocating for critical legislation like H.R.3597, the Protecting Circuit Boards and Substrates Act, and why American PCB manufac…
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From FDA PMA to Health Canada: A Guide to Licensing High-Risk Medical Devices
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3:43Holding FDA PMA approval is a significant achievement, but what does it mean for entering the Canadian market? This episode breaks down the essential steps and requirements for obtaining a Health Canada Medical Device Licence for your high-risk device. We explore how to leverage your existing FDA data while navigating Canada's unique regulatory lan…
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From FDA 510(k) to EU CE Mark: Bridging the Regulatory Gap
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3:49Think your FDA 510(k) is a fast track to a European CE Mark? This episode uncovers the critical gaps between the two regulatory systems. We explore the fundamental differences in philosophy, from the FDA's "substantial equivalence" model to the EU MDR's lifecycle approach, and detail the extra work required in quality management, clinical evidence,…
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Working in ransomware response, investigation and recovery | John Price
35:58
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35:58Get your FREE Cybersecurity Salary Guide: https://www.infosecinstitute.com/form/cybersecurity-salary-guide-podcast/?utm_source=youtube&utm_medium=podcast&utm_campaign=podcast John Price of SubRosa joins today's Cyber Work Podcast to share insights from his unique career path spanning UK military counterintelligence, banking cybersecurity and foundi…
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Leveraging Your FDA De Novo for Brazilian Market Access
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3:31This episode breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the De Novo is a powerful asset, it does not grant automatic approval. We cover the essential steps, from determining your device's risk classification under Brazilian regulations to understanding the dif…
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Beyond FDA Clearance: A Guide to China's NMPA Medical Device Registration
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3:18
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3:18This episode demystifies the process for registering an FDA-cleared medical device in China. We explore why FDA approval is only the first step and detail the unique requirements of the National Medical Products Administration (NMPA), including classification, local agent representation, in-country testing, and clinical data validation for the Chin…
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Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
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3:47This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. We explore the key updates from the previous version, focusing on the integration of risk management, new planning requirements, and operational changes that impact how manufacturers design and conduct…
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Navigating the New Rules of Medical Device Risk: ISO 14971:2019 Explained
3:27
3:27
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3:27This episode demystifies the latest version of the essential risk management standard, ISO 14971:2019. We explore the critical updates manufacturers must understand, from the expanded scope covering the entire device lifecycle to the proactive requirements for post-market activities. Learn about the key definition changes and the enhanced focus on …
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S6E30 Jake Whinnery | Resources for Interviewing & Landing Engineering Jobs
53:14
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53:14Send us a text Jake shares his engineering journey, insights into technical interviews, and strategies for young engineers to succeed in the hardware industry. He discusses his experiences at companies like Tesla and Relativity Space and how he created Hardware is Hard to help mechanical engineers land top-tier jobs. Main Topics: Importance of inte…
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From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
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3:25This episode breaks down the essential updates from ISO 15223-1:2021 and its recent 2025 amendment. We explore the new symbols for medical devices, translations, and sterilization, and detail the critical shift from the 'EC REP' to the 'EU REP' symbol, explaining the reasons and the compliance timeline for manufacturers.Key Questions:• What is ISO …
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Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety
3:45
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3:45This episode breaks down the critical updates in IEC 60601-1 Edition 3.2, the mandatory electrical safety standard for medical devices. We cover the key changes from Amendment 2, including alignment with ISO 14971, the adoption of IEC 62368-1 for IT equipment, and refined requirements for Means of Protection (MOP), helping manufacturers understand …
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The Golden Key: How ISO 13485 Unlocks Global MedTech Markets
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3:36This episode demystifies ISO 13485:2016, the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. We explore the standard's core requirements, the critical changes introduced in the 2016 revision, and why compliance is the essential key for any MedTech company aiming to achieve regulatory approval…
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From security audits to privacy consulting: Building a GRC practice | Will Sweeney
42:20
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42:20Get your FREE Cybersecurity Salary Guide: https://www.infosecinstitute.com/form/cybersecurity-salary-guide-podcast/?utm_source=youtube&utm_medium=podcast&utm_campaign=podcast Will Sweeney, founding and managing partner of Zaviant, joins the Cyber Work Podcast to discuss the evolving landscape of data privacy and GRC (governance, risk and compliance…
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Intuitive's Newest Robot: A Surgeon's Sense of Touch
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3:12This episode unpacks the landmark FDA clearance of Intuitive Surgical's da Vinci 5, the next generation in soft-tissue robotics. We explore its groundbreaking features, including Force Feedback technology that gives surgeons a sense of touch, a 10,000-fold increase in computing power, and enhanced 3D visualization. We also analyze its strategic imp…
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From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants
2:55
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2:55This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how its bioactive matrix eliminates the need for painful bone grafts, significantly reducing surgery time, and how its integrated recovery app is transforming postoperative care through remote mo…
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The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis
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3:03This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical therapists in the United States. We analyze the market drivers, patient benefits, and the critical market access hurdles, including payer reimbursement, that innovative MedTech companies face …
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From Niche to Mainstream: The AI Revolution in Wearable Health Tech
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3:05This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical devices to mainstream wellness tools. We delve into the technological drivers, such as advanced sensors and on-device AI, and the market catalysts, including the 2024 Medicare coverage expansion, t…
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AI and the Heart: How 3D Modeling is Transforming Cardiac Diagnosis
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2:50This episode delves into the revolutionary HeartFlow platform, an AI-powered diagnostic tool that creates personalized 3D models of the heart from CT scans. We explore how this technology is transforming the diagnosis of coronary artery disease by offering a non-invasive, highly accurate alternative to traditional methods, its key regulatory milest…
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S6E29 Joshua Tarbutton | Lessons From the Military Applied to Engineering
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50:33Send us a text Joshua Tarbutton shares his journey from military service to engineering entrepreneurship, discussing how military discipline and leadership principles can transform engineering culture and workplace dynamics. Main Topics: Military influence on engineering leadership Restoring dignity in engineering workplaces Creating psychological …
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Send us a text Sign up for a free account at https://www.thewave.engineer/ Then, access your 50% discount code for PDX 2025 here: https://www.thewave.engineer/product-development-expo/dfm-days/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with…
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KIMES 2025: Your Gateway to South Korea's High-Tech Medical Device Market
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2:58This episode explores South Korea's dynamic medical device market, providing a strategic preview of the upcoming Korea International Medical & Hospital Equipment Show (KIMES) in March 2025. We analyze the key growth trends, including the rapid adoption of AI in diagnostic imaging and the boom in portable and wearable health technologies. The discus…
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Guangzhou 2024: Inside China's 5G Smart Hospital Revolution
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3:12This episode dives into the upcoming Greater Bay Area International Medical Device Expo in Guangzhou, China, scheduled for September 23-25. We explore the event's core themes of "Smart Hospitals" and "5G Medical Ecology," detailing how these trends are shaping the future of MedTech in one of the world's most dynamic economic zones. This is a must-l…
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Inside Riyadh's 2024 Global Health Exhibition: Your Gateway to Saudi MedTech
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2:29This episode dives into the 2024 Global Health Exhibition in Riyadh, the largest healthcare event in Saudi Arabia. We explore how this event serves as a crucial gateway for medical device companies looking to capitalize on the Kingdom's Vision 2030, focusing on opportunities in government procurement, high-end equipment imports, and partnerships dr…
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From "dead-end job" to CEO: Building an IT consulting business | John Hansman
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45:40Get your FREE Cybersecurity Salary Guide: https://www.infosecinstitute.com/form/cybersecurity-salary-guide-podcast/?utm_source=youtube&utm_medium=podcast&utm_campaign=podcast John Hansman of Truit joins today's Cyber Work episode to share his journey from a "dead-end job" in electronic security to building a thriving managed IT services company. As…
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Your Gateway to Japan's Healthcare Market: Navigating MEDICAL JAPAN 2025
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2:50This episode provides a detailed guide to the upcoming MEDICAL JAPAN trade show in Tokyo, a vital event for MedTech companies targeting the Japanese and Asian markets. We explore the event's scale, the diverse sectors it covers, and the strategic opportunities it offers for networking, partnerships, and market entry.Key Questions:• What is MEDICAL …
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Accessing Latin America: Key Insights from Hospitalar 2024
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2:32This episode unpacks Hospitalar 2024, the most influential healthcare trade fair in Latin America. We explore the key trends, market demands, and strategic opportunities that emerged from the event in São Paulo, Brazil, providing essential insights for any MedTech company targeting the region.• What makes Hospitalar the most important healthcare ev…
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Arab Health 2025: Your Strategic Gateway to the MENA MedTech Market
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2:58This episode explores the immense strategic importance of the Arab Health exhibition, taking place in Dubai from January 27-30, 2025. We delve into why this event is the premier gateway for medical device companies, particularly those in high-end imaging, to access the rapidly growing Middle East and North Africa (MENA) market. Discover the key tre…
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Decoding CMEF 2025: Your Gateway to China's MedTech Boom
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2:52The China International Medical Equipment Fair (CMEF) in Shanghai is the premier gateway to the Asia-Pacific's booming MedTech sector. This episode offers a deep dive into the upcoming 2025 event, exploring its massive scale, dual focus on primary and high-end care, and its unique role in integrating the entire industry supply chain. We highlight t…
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One Audit, Six Markets? MDSAP vs. ISO 13485 in Southeast Asia
4:11
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4:11We explore the Quality Management System requirements for medical device manufacturers in six key Southeast Asian markets: Singapore, Malaysia, Vietnam, the Philippines, Thailand, and Indonesia. The episode details the mandatory ISO 13485 standard and clarifies where the Medical Device Single Audit Program (MDSAP) is, and importantly, where it isn'…
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S6E28 Paul Vizzio | Engineering Naval Submarines, Pet Products, & Elite Sports Training Machines
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50:01Send us a text In today’s episode, Paul will explore how he scales hardware teams, builds for manufacturability, navigates supply chain complexity, mentors engineers, and embraces community‑driven innovation. Get ready for insights on leadership, prototyping, and bringing hardware to life from idea to market. Main Topics: Proteus Motion's V1 and V2…
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Unlocking Global Opportunities at MEDICA 2024
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3:02This episode provides a comprehensive guide to MEDICA 2024 in Düsseldorf, the world's leading trade fair for the medical technology industry. We explore the event's massive scale, its key focus areas, the hot topics for this year like AI and digital health, and why it is a critical event for any company looking to succeed in the global MedTech mark…
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The Titans of MedTech: A Guide to the World's 3 Largest Industry Trade Shows
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3:20This episode unpacks the three largest and most influential medical device trade shows on the planet. We explore the unique characteristics of MEDICA in Germany, Arab Health in Dubai, and CMEF in China, providing medical device professionals with the essential intelligence needed to strategically plan their global outreach, networking, and market e…
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Send us a text Sign up for a free account at https://www.thewave.engineer/ Then, access your 50% discount code for PDX 2025 here: https://www.thewave.engineer/product-development-expo/dfm-days/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with…
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Unlocking the Malaysian Medical Device Market: A 2024 Regulatory Guide
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2:36This episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including rece…
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Brazil's New MedTech Timeline: Understanding ANVISA Fees and Review Cycles Under RDC 751/2022
3:53
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3:53This episode provides a detailed overview of the medical device registration process in Brazil under the new RDC 751/2022 regulation. We explore the two primary regulatory pathways, Notificação and Registro, their associated timelines, and the structure of official ANVISA fees. Learn about the critical role of risk classification and Brazilian Good…
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What Every Engineer Should Know About Contract Manufacturers
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0:55Send us a text Webinar: What Every Engineer Should Know About Contract Manufacturers Register here: https://www.thewave.engineer/store/product/31-what-every-engineer-should-know-about-working-with-a-contract-manufacturer/ About Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers …
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Malaysia MedTech: The Risks and Rewards of Self-Licensing
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3:06This episode delves into the strategic option for foreign MedTech companies to use their own Malaysian subsidiary as the official license holder for their medical devices. We unpack the regulatory framework under the Medical Device Act 2012, highlighting the complete control this model offers over registrations and commercial activities. However, i…
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