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Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s been gaining a lot of traction in the industry, because some recent standards have focused on risk management. Today’s guest has seen companies take their risk management plan directly from their design controls and paste them into their regulatory submission forms. This is not a correct way to approach risk management, because it gives an incomplete picture. Mike Drues, the president of Vascular Sciences, has been a frequent guest on our show. Not only do we listen to him, but the FDA and Health Canada do, too, because Mike works with these regulatory agencies in addition to working with medical device companies. Today we’re talking about risk management. Mike has a three (plus one bonus) bucket approach to dealing with this important topic. Some of the ideas that we discuss today include: ● Mike’s systematic approach to risk management: three “buckets” he uses when developing his plans. ● How to measu