Jon Speer, risk management

MedTech Blunders in Risk Management

By MedTech Intelligence Staff
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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