Description

Here we present a Risk Management Report template, to be completed in alignment with the related risk management plan template.

4EasyReg provides a set of documents to fully prepare your risk management file, from risk management plan to hazard analysis, from risk management procedure to benefit/risk analysis.

Tailored by seasoned regulatory experts, our template empowers medical device manufacturers to consolidate and articulate risk management efforts with precision and confidence. It encompasses all pivotal elements delineated in ISO 14971 and ISO 24971, ensuring steadfast adherence to international standards and regulatory expectations.