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 regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.
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Medical Device Global Market Access
FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions
Sep 29, 20265 min
The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical Devices (RASDs). This episode breaks down the key recommendations covering non-clinical testing, clinical data requirements, and specific labeling considerations. We also highlight the critical November 24, 2026, deadline for submitting comments and provide practical steps for manufacturers to align their regulatory strategies with the FDA's current thinking. Key Questions: - What is the scope of the FDA's new draft guidance on Robotically-Assisted Surgical Devices? - When is the deadline to submit comments on this new guidance? - What specific non-clinical testing does the FDA now recommend for RASD premarket submissions? - Under what circumstances will clinical data be required for a new or modified RASD? - How have labeling and training requirements changed for robotic surgery systems? - What are the key human factors considerations the FDA emphasizes for these devices? - How should manufacturers adjust their 510(k), De Novo, or PMA strategies in light of this guidance? - What practical steps should my regulatory team take today to prepare? Sources: - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/robotically-assisted-surgical-devices-premarket-submissions - https://www.fda.gov/news-events/cdrh-new-news-and-updates/september-24-2026-robotic-medical-devices-public-workshop-evaluating-benefit-risk-robotic-medical How Pure Global can help: Navigating new FDA guidance for complex devices like Robotically-Assisted Surgical Devices requires deep regulatory expertise. Pure Global helps MedTech and IVD companies streamline global market access with end-to-end regulatory consulting. Our experts can develop efficient regulatory strategies for your 510(k), De Novo, or PMA submission, prepare technical dossiers using advanced AI, and act as your local representative. We combine global reach with local expertise to get your products to market faster. For support with your US market access strategy, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI-powered regulatory tools and device database at https://pureglobal.ai.
EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026
Sep 28, 20265 min
This episode covers the significant procedural change announced in MDCG 2026-4, where medical device and IVD manufacturers will now be responsible for uploading the Summary of Safety and (Clinical) Performance (SSCP/SSP) to the EUDAMED database. We explain how this shifts the task from Notified Bodies to manufacturers of Class III, implantable, and Class C/D IVD devices, effective with the launch of new EUDAMED functionality in October 2026. The host details the practical implications and provides actionable steps for regulatory and quality teams to prepare for this mandatory handover. Key Questions: - What is the MDCG 2026-4 position paper and how does it change EUDAMED uploads? - When will manufacturers be required to upload the SSCP and SSP to EUDAMED themselves? - Which device classes are affected by this new EUDAMED responsibility? - What will the Notified Body's role be after this change takes effect in October 2026? - How does this shift impact the overall EUDAMED compliance workflow? - What are the first steps to prepare our team for direct EUDAMED submissions? - How should we update our Quality Management System (QMS) for this new requirement? - Why is the European Commission making this change? - What happens if the uploaded SSCP/SSP is not validated by the Notified Body? Sources: - https://www.meddeviceguide.com/en/meddevice-blog/mdcg-2026-4-eudamed-sscp-ssp-upload How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We help you navigate complex requirements like the EU MDR, IVDR, and the EUDAMED database. Our experts can develop your regulatory strategy, prepare technical dossiers, and act as your local representative in over 30 markets. By combining in-country expertise with advanced AI tools, we ensure your submissions are efficient and compliant, helping you maintain market presence and adapt to changes like the new SSCP/SSP upload process. Visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai to learn more.
Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules
Sep 27, 20265 min
Brazil's ANVISA has opened Public Call No. 4/2026, seeking industry feedback on a major revision of its medical device post-market vigilance (Tecnovigilância) framework. With a specific focus on the challenges posed by Software as a Medical Device (SaMD) and AI, this consultation offers a critical opportunity for manufacturers to influence future regulations. This episode breaks down the scope of the proposed changes, the strategic importance of participating, and the key deadline of mid-October 2026 for submitting feedback. Key Questions: - What is ANVISA's Public Call No. 4/2026 about? - How is Brazil updating its medical device post-market vigilance (Tecnovigilância) framework? - Why are Software as a Medical Device (SaMD) and AI a specific focus of this consultation? - What is the deadline for manufacturers to submit feedback to ANVISA? - Who is most affected by these proposed changes? - What are the key challenges in post-market surveillance for AI-enabled medical devices? - How can manufacturers strategically influence the future of Brazilian medical device regulation? - What practical steps should regulatory teams take right now? Sources: - https://www.smart-mdr.com/anvisa-launches-consultation-on-medical-device-vigilance-framework/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts in Brazil can help you understand ANVISA's proposed vigilance changes, assess the impact on your SaMD and AI products, and formulate a strategic response to Public Call No. 4/2026. We act as your local representative, manage technical submissions, and provide continuous regulatory monitoring to ensure you stay compliant. Leverage our expertise to shape regulations and secure your market presence in Brazil. Visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.
EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials
Sep 26, 20266 min
This episode details the September 9, 2026 update to the EU's MDCG 2020-16 guidance, Revision 5. We explain the crucial clarifications on classifying in-vitro diagnostic (IVD) quality control (QC) materials under the IVDR. The discussion focuses on the distinction between QC materials with manufacturer-assigned values versus those with only indicative values, and how this directly impacts a product's risk class and its required conformity assessment pathway, including the need for notified body involvement. Key Questions: - What is MDCG 2020-16 Revision 5 and why is it important for IVD manufacturers? - How does the updated guidance change the classification of quality control (QC) materials? - What is the key difference between QC materials with "assigned values" versus "indicative values"? - How does this classification impact the required conformity assessment route under the IVDR? - If a QC material is for a Class D assay, what is its new classification? - Why are non-assigned value QC materials typically considered Class A? - What immediate steps should regulatory teams take to comply with this guidance? - Does this change require notified body involvement for products previously self-certified? - How should manufacturers update their technical documentation and labeling? Sources: - https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en How Pure Global can help: Pure Global provides end-to-end regulatory consulting for IVD and MedTech companies navigating complex regulations like the EU IVDR. Our experts develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to streamline market access. By combining local expertise with advanced AI, we help you correctly classify your devices, engage with notified bodies, and ensure your documentation meets the latest standards like MDCG 2020-16. To accelerate your global market access, visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free regulatory AI tools and database at https://pureglobal.ai.
Brazil ANVISA High-Risk Device Registration: Navigating Public Consultation 1248
Sep 25, 20265 min
Brazil's ANVISA has released Public Consultation No. 1248, proposing a major overhaul of the registration process for Class III and IV high-risk medical devices. This episode breaks down the key changes, including the shift to an IMDRF-aligned technical dossier, heightened requirements for clinical evidence and risk management, and the critical 45-day feedback period closing in October 2026. We discuss who is affected and outline practical steps for manufacturers to prepare and provide feedback before the deadline. Key Questions: - What is ANVISA's Public Consultation No. 1248 and what does it propose for high-risk devices? - How will the technical dossier structure for Class III and IV devices change in Brazil? - What new requirements for clinical evidence and risk management are being introduced? - How does this proposal align Brazil's regulations with international standards like IMDRF? - What is the deadline for submitting feedback on this important consultation? - Which device manufacturers will be most impacted by these regulatory changes? - What immediate actions should regulatory and quality teams take to prepare? - How can manufacturers effectively provide input to ANVISA before the final rule is published? - What are the long-term implications for market access in Brazil? Sources: - https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/cp-propoe-nova-regra-para-registro-de-dispositivos-medicos - https://www.gov.br/anvisa/pt-br/assuntos/consultas-publicas/consultas-publicas-em-andamento How Pure Global can help: Navigating Brazil's evolving regulatory landscape for high-risk devices requires local expertise and strategic planning. Pure Global provides end-to-end support for ANVISA submissions, from developing a regulatory strategy and conducting gap analyses to compiling and submitting technical dossiers. Our team of local experts in Brazil, combined with advanced AI tools, ensures your submissions are compliant with the latest requirements, minimizing delays and accelerating your path to market. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI regulatory intelligence tools and device database at https://pureglobal.ai.
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