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 greenlight.guru 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.