Jon Speer, risk management

MedTech Blunders in Risk Management

By MedTech Intelligence Staff
1 Comment
Jon Speer, risk management

A look at some common mistakes medical device companies make when approaching risk.

Risk management has traditionally involved siloes, with some difference in perspective from industry to regulators to standards bodies. With a movement toward speaking the same language, device companies should also reexamine their approach to risk management. “When we think about designing or manufacturing….our intent is good minded [and] I think it’s risk based, but some times our documentation, our records [and] our activities don’t always align with our intent,” explained Jon Speer, founder and vice president of QA/RA at during the MedTech Intelligence risk management conference last month. “And sometimes our activities are simply checkbox activities.”

What other mistakes do companies make? Watch the video to find out.

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  1. Ary Saaman

    Now that Risk Management is everywhere and here to stay, it is indeed time for a good discussion about Risk Management among all stakeholders and what we may realistically do for and expect from good Risk Management practices and (also very important) what not. Whereas the over-all purpose of Risk Management is to aid us in ensuring that medical devices will be safe (and whose benefits outweigh their risks) over their entire life cycle, Risk Management is not a substitute for Quality Management.

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