Producing safe medical devices is about more than just schematics. It is a social process with people having a huge impact on how safe the result is. All the bl

Producing safe medical devices is about more than just schematics. It is a social process with people having a huge impact on how safe the result is. All the blueprints in the world have no value if you don’t know whether they’ve been followed and the materials used are correct. And when there are defects you need to have socialized how people are to respond to those defects or your not building a competent organization. I see many comments about blueprints on here that miss the point. It’s like saying your software product is just the source code. The reality is that you have to build a competent knowledgeable organization around those blueprints or what you’re making will kill or injure patients.