Episode Thumbnail
Episode 54  |  21:09 min

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54  |  21:09 min  |  11.07.2019

Challenges with Applying Risk Management Throughout the Manufacturing Process

00:00
00:00
This is a podcast episode titled, Challenges with Applying Risk Management Throughout the Manufacturing Process. The summary for this episode is: Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company’s approach to manufacturing processes as they apply to risk management. Some of the highlights of the show include: ● Information about Jim’s background and about Regality Consulting. ● Thoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decision that’s made throughout the manufacturing process. ● Why the adoption of ISO 14971 has been so problematic for medical device companies. ● Why it’s important to consider risk management before planning design. ● Considerations to keep in mind when outsourcing or getting components and materials from other organizations. ● Thoughts on validating processes and sampling based on risk assessment and management. ● An example that Jim has seen regarding a lack of sufficient risk management: the takeaway is to address risk management now; don’t wait until you get a warning letter.
Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company’s approach to manufacturing processes as they apply to risk management. Some of the highlights of the show include: ● Information about Jim’s background and about Regality Consulting. ● Thoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decision that’s made throughout the manufacturing process. ● Why the adoption of ISO 14971 has been so problematic for medical device companies. ● Why it’s important to consider risk management before planning design. ● Considerations to keep in mind when outsourcing or getting components and materials from other organizations. ● Thoughts on validating processes and sampling based on risk assessment and management. ● An example that Jim has seen regarding a lack of sufficient risk management: the takeaway is to address risk management now; don’t wait until you get a warning letter.

More Episodes

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Understanding the UDI System for Medical Devices

Understanding the UDI System for Medical Devices

Shaking Things Up: What's Next for the Global Medical Device Podcast

Shaking Things Up: What's Next for the Global Medical Device Podcast

How Augmented Reality (AR) is Revolutionizing Healthcare

How Augmented Reality (AR) is Revolutionizing Healthcare

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care