Risk Management is Much More Than a Spreadsheet
Medical device manufacturers must reduce the risk of potential hazards and harm when users operate their devices. Device failures from intended and unintended use must be identified, understood, and controlled. Managing risks in siloed document-driven processes makes it difficult for medical device manufacturers to connect all risk-related data and understand the impact of product changes coming from design and R&D. Manufacturers need a system that brings quality, risk, and product data together in one place.