A risk management plan (RMP) is an important tool used to detect, characterize, assess and minimize risks associated with the use of a medical device.
A risk management program includes three main steps:
- Characterization of the medical device safety profile, which includes both known safety information and what is still unknown about the product.
- Planning pharmacovigilance activities designed to characterize known risks, identify new risks and expand knowledge of the product safety profile.
- Planning and implementing a risk mitigation plan, as well as assessing the effectiveness of these activities.
To the article Risk Management, Risk Analysis and Risk Assessment for FDA medical devices, software and medicines according to FDA, ISO 13485, ISO 14971