For medical device manufacturers, these internationally developed technical documents (like ISO 14971 for Risk Management, ISO 10993 for Biocompatibility etc.) are more than just guidelines—they are a very efficient path to market. By declaring conformity to these standards, medical device manufacturers provide the FDA with a proven "blueprint" for device’s safety and performance, significantly streamlining the premarket review process. For example, if a medical device manufa

FMEA (Failure Mode and Effects Analysis) is a proactive, bottom-up risk assessment methodology. Its core purpose is to: -Identify...