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Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm
FromGlobal Medical Device Podcast powered by Greenlight Guru
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
37 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
Do you love quality and regulatory and keeping up with all things related to the medical device industry? There’s never a shortage of changes to learn about. Greenlight Guru is traveling around the country to bring medical device professionals together and provide up-to-date insights on the latest quality and regulatory trends.
This special episode features a recording of the industry panel from the Greenlight Guru True Quality Roadshow in Atlanta, presented by the Global Center for Medical Device Innovation (GCMI) and Rook Quality Systems.
The panelists include Sarah Cohen, senior engineering project manager at GCMI; Ronald Bracken, principal at Paladin Biomedical Consultants; and Ward Broom, chief operating officer at Intent Solutions.
Some of the highlights of the show include:
● Panel experts identify which programs and regulations have made the biggest impact on their businesses and the industry.
● Changes aren’t limited to the United States. European (EU) MDR made changes that require interpretation of what each country and its regulatory agencies want.
● Turn to experts to answer questions and learn how to apply and implement medical device regulations.
● Panel experts describe the pros and cons of a regulatory strategy for a Class I medical device.
● Educating and training companies on the importance of regulations is critical to help them navigate all the changes in the medical device industry.
● Medical device startups need to identify what is non-negotiable to build a culture of quality and train employees.
● A quality system is set up for a reason. Companies should focus on making products that they’re proud of and help patients.
● Biggest mistake is when inventor puts technology before patients: Who am I making it for? What do they want? What does it have to do? How to deliver it?
This special episode features a recording of the industry panel from the Greenlight Guru True Quality Roadshow in Atlanta, presented by the Global Center for Medical Device Innovation (GCMI) and Rook Quality Systems.
The panelists include Sarah Cohen, senior engineering project manager at GCMI; Ronald Bracken, principal at Paladin Biomedical Consultants; and Ward Broom, chief operating officer at Intent Solutions.
Some of the highlights of the show include:
● Panel experts identify which programs and regulations have made the biggest impact on their businesses and the industry.
● Changes aren’t limited to the United States. European (EU) MDR made changes that require interpretation of what each country and its regulatory agencies want.
● Turn to experts to answer questions and learn how to apply and implement medical device regulations.
● Panel experts describe the pros and cons of a regulatory strategy for a Class I medical device.
● Educating and training companies on the importance of regulations is critical to help them navigate all the changes in the medical device industry.
● Medical device startups need to identify what is non-negotiable to build a culture of quality and train employees.
● A quality system is set up for a reason. Companies should focus on making products that they’re proud of and help patients.
● Biggest mistake is when inventor puts technology before patients: Who am I making it for? What do they want? What does it have to do? How to deliver it?
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer: One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation... by Global Medical Device Podcast powered by Greenlight Guru