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.


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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.

Links and Resources:

James Gianoutsos on LinkedIn

Regality Consulting

ISO 14971

Definitive Guide to ISO 14971 Risk Management

Greenlight Guru

Quotes by Jim:

“Risk is sometimes an afterthought; people sometimes wait way too late.”

“Risk assessment will set the stage for any type of incoming inspection, sampling, process validation, and final release testing.”

“What it really comes down to is risk-based decision making.”




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