Mastering Medical Device Risk Assessment with ISOXpress ISO 14971 focuses on executing regulatory compliance for product safety using streamlined ISOXpress tools. ISO 14971 is the definitive, globally recognized international standard for managing medical device risks throughout their entire life cycle—from concept to post-market disposal.
The ISOXpress toolkit (which transitioned its brand footprint under IMSXpress / AQA Company) provides a dedicated standalone software tool, procedural templates, and a 9-step hazard analysis manual. These solutions help small-to-medium medical device manufacturers translate abstract regulatory jargon into clear, auditable workflows. Core Concepts of ISO 14971
ISO 14971 evaluates medical device risk strictly as a function of patient and operator safety, defining risk through two distinct metrics: Severity: How much physical harm can the hazard cause?
Probability: How likely is the sequence of events to cause that harm? The 9-Step ISOXpress Risk Methodology
The ISOXpress Medical Device Risk Analysis Manual outlines a structured framework to map out hazards into a compliant Risk Management File (RMF):
Leave a Reply