Global Medical Device Podcast powered by Greenlight Guru Podcast
1) CDRH Proposed Guidance for FY 2023
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses import...Show More
2) Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s ...Show More
Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
43:23 | Dec 14th, 2022
3) The Future of Healthcare & How We Get There
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in collaboration with each o...Show More
4) What "Exempt" Means with Respect to Medical Devices & Regulatory
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?This is the focu...Show More
5) Developing a Regulatory Strategy
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins hi...Show More
6) We Achieved ISO Certification! Now What?
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.Mark Alpert is the Director of Quality at Gree...Show More
7) The Future of Reprocessed Used Medical Equipment
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the futur...Show More
8) The Importance of Cervical Cancer Screening in the U.S.
The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features ...Show More
9) Customer Discovery for Medical Device Companies
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies.Kari Haab has been working in ...Show More
10) EUA and the Impending Transition
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; m...Show More