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In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.
Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.
Key TimestampsQMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality and regulatory compliance.
QMSR: FDA’s new quality regulation aligning with ISO 13485:2016.
483 Form: Issued by the FDA when investigators find conditions that may violate the FD&C Act.
Family Office Investment: Wealth management firms that are increasingly investing in MedTech startups.
Feedback Welcome!Enjoyed the episode? Please leave us a review on iTunes and tell us what you want to hear next. Your feedback helps us grow!
Drop us a note at [email protected]
🎁 SponsorsThis episode is sponsored by Greenlight Guru – the only quality management system (QMS) and electronic data capture (EDC) software built specifically for the MedTech industry. Want to streamline compliance and reduce your time to market?
👉 Learn more at greenlight.guru and mention this podcast for a special demo offer.
In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.
Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.
Key TimestampsQMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality and regulatory compliance.
QMSR: FDA’s new quality regulation aligning with ISO 13485:2016.
483 Form: Issued by the FDA when investigators find conditions that may violate the FD&C Act.
Family Office Investment: Wealth management firms that are increasingly investing in MedTech startups.
Feedback Welcome!Enjoyed the episode? Please leave us a review on iTunes and tell us what you want to hear next. Your feedback helps us grow!
Drop us a note at [email protected]
🎁 SponsorsThis episode is sponsored by Greenlight Guru – the only quality management system (QMS) and electronic data capture (EDC) software built specifically for the MedTech industry. Want to streamline compliance and reduce your time to market?
👉 Learn more at greenlight.guru and mention this podcast for a special demo offer.