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7 Habits of Highly Effective True Quality Medical Device Professionals
FromGlobal Medical Device Podcast powered by Greenlight Guru
7 Habits of Highly Effective True Quality Medical Device Professionals
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
44 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
What is true quality? How do you achieve it?
In this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professionals.
True quality does not simply refer to being compliant with regulations - but going above and beyond. It’s your responsibility to improve the quality of life.
Some of the highlights of the show include:
● Habit 1: Quality management system (QMS) should be simple and right sized; customize it to describe your business’ processes.
● Habit 2: Move away from paper-based approaches - may make your QMS fragile and not scale; digitize documentation with a purpose-based solution.
● Habit 3: Always be audit ready; if the FDA is coming, you shouldn’t behave differently or hide something. Be transparent, and let FDA show up anytime.
● Habit 4: Implement risk-based approaches and decision making; understand the scope, magnitude, and potential impact of issues and complaints.
● Habit 5: Be proactive rather than reactive to events; don’t wait for something to happen to do something about it. Monitor, evaluate, track, trend, and take action.
● Habit 6: Break down silos/barriers by understanding the purpose and benefits of regulations and regulatory agencies.
● Habit 7: Shift from compliance-minded to true quality focus; you develop, design, and test a product to make sure it’s safe and effective, but the ultimate power is knowing that it’s for real physicians and patients.
Links:
Mike Drues
Greenlight Guru
510(k)
The 7 Habits of Highly Effective People by Stephen Covey
Quotes:
“We’re all in this to improve the quality of life. We all have a quality role that we play into this process.” - Jon Speer
“Sometimes, convincing companies to go above and beyond is what is required. It’s not always an easy thing to do.” - Mike Drues
“Sometimes, people look at a quality system as a burden. I want you to look at it as something you get to do that describes your business’ processes.” - Jon Speer
“If you’re doing all the things that you should be doing anyway, then you have absolutely nothing to worry about.” - Mike Drues
In this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professionals.
True quality does not simply refer to being compliant with regulations - but going above and beyond. It’s your responsibility to improve the quality of life.
Some of the highlights of the show include:
● Habit 1: Quality management system (QMS) should be simple and right sized; customize it to describe your business’ processes.
● Habit 2: Move away from paper-based approaches - may make your QMS fragile and not scale; digitize documentation with a purpose-based solution.
● Habit 3: Always be audit ready; if the FDA is coming, you shouldn’t behave differently or hide something. Be transparent, and let FDA show up anytime.
● Habit 4: Implement risk-based approaches and decision making; understand the scope, magnitude, and potential impact of issues and complaints.
● Habit 5: Be proactive rather than reactive to events; don’t wait for something to happen to do something about it. Monitor, evaluate, track, trend, and take action.
● Habit 6: Break down silos/barriers by understanding the purpose and benefits of regulations and regulatory agencies.
● Habit 7: Shift from compliance-minded to true quality focus; you develop, design, and test a product to make sure it’s safe and effective, but the ultimate power is knowing that it’s for real physicians and patients.
Links:
Mike Drues
Greenlight Guru
510(k)
The 7 Habits of Highly Effective People by Stephen Covey
Quotes:
“We’re all in this to improve the quality of life. We all have a quality role that we play into this process.” - Jon Speer
“Sometimes, convincing companies to go above and beyond is what is required. It’s not always an easy thing to do.” - Mike Drues
“Sometimes, people look at a quality system as a burden. I want you to look at it as something you get to do that describes your business’ processes.” - Jon Speer
“If you’re doing all the things that you should be doing anyway, then you have absolutely nothing to worry about.” - Mike Drues
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson: Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical De... by Global Medical Device Podcast powered by Greenlight Guru