Risk Management Plan
Have confidence that you are going in the right direction. A Risk Management Plan from BSC is tailored to your needs and based on extensive experience bringing Risk Files through regulatory approval. This avoids false starts, wasted work, or worst of all a rejection when you go to file.
The Risk Management Plan defines the process that will be used to identify and control risk of harm to the patient or user throughout all levels of the engineering effort. This document accomplishes the following:
Identify standards to comply to (ISO 14971:2012 recommended)
Identify guidance documents from the FDA that need consideration (e.g. Safety Assurance Cases for Infusion Pumps)
Define structure of top level Hazards Analysis
Determine subsystems requiring their own FMEA
Define qualitative occurrence and severity levels
Define risk levels (Acceptable, ALAP vs ALARP, Unacceptable)
Define how quantitative occurrence is calculated (P1*P2)
Determine if pre-mitigation occurrence and risk will be included
Define the relationships between risk documents
Define process for determining if a Risk Benefit Analysis is needed
Define process for secondary hazards
A well defined risk management process allows the engineering team to focus on designing the safest device possible.