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MDR Classification
This document outlines the duration of use of the product along with the regulatory classification of a medical device and a justification why it falls under that specific class according to Annex VIII of MDR 2017/745.
This document provides an overview of the key regulatory details for a medical device, including its intended use, patient population, users, contraindications, and principles of operation.
The risk assessment documents your risk analysis based on ISO 14971 which identifies the foreseeable risks that will be encountered by users while they use your device. The risk assessment contains your software risk classification, your risk analysis (a preliminary hazard analysis) and risk controls that should be implemented based on unacceptable risks.
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Risk Management Plan
The Risk Management Plan outlines the risk policy and criteria for risk acceptance in accordance with ISO 14971:2019 and ISO/TR 24971:2020 standards. It documents the integration of risk management activities within the software development lifecycle, addressing risk identification, evaluation, and control measures.
