Episode Thumbnail
Episode 99  |  36:46 min

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99  |  36:46 min  |  11.07.2019

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

00:00
00:00
This is a podcast episode titled, Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm. The summary for this episode is: 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?
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?

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis