By Edwin Waldbusser
FDA expects that as part of a product development program risk management will be conducted and risks will be mitigated as far as practical. Risk Analysis is required in a FDA product submission.
FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis, described in ISO 14971, is the most powerful of the risk management tools , but it is very confusing.
Many new concepts are introduced. We will explain these concepts and provide examples so that you can expertly perform the process. Templates will be provided. Handouts are hazard analysis forms and HA report template.