Risk Management Report

Our Risk Management Report Template is specifically designed to help medical device manufacturers comply with EU MDR 2017/745 and ISO 14971 requirements for risk management. This fully editable and comprehensive template guides you through the process of identifying, analyzing, evaluating, and controlling risks associated with your medical device, ensuring a structured approach to maintaining safety and performance.

Key Features:

• Compliant with EU MDR & ISO 14971: The template is aligned with the risk management requirements outlined in EU MDR 2017/745 and ISO 14971, ensuring full compliance with regulatory standards.
• Comprehensive Risk Management Process: Covers all stages of the risk management lifecycle, from initial risk identification and analysis to risk control, evaluation of residual risks, and post-market surveillance (PMS).
• Fully Customizable: Adaptable for all types of medical devices, regardless of their risk classification (Class I, IIa, IIb, or III), and designed to accommodate different device complexities.
• Integrated Risk/Benefit Analysis: Sections for performing a detailed risk/benefit analysis, helping you balance potential device risks with clinical benefits, as required by both EU MDR and ISO 14971.
• Traceability Matrix: Includes a traceability matrix to link identified risks, relevant hazardous situation and harms, estimation of probability and severity before and after risk controls measures, corresponding control measures, ensuring that all identified risks are addressed and mitigated.

Why Choose This Template?

• Regulatory Confidence: Ensures that your risk management activities are fully documented and compliant with the stringent requirements of EU MDR and ISO 14971, giving you confidence in regulatory submissions.
• Streamlined & Time-Saving: Pre-structured sections allow for efficient completion of the risk management report, minimizing the effort required to meet compliance standards.
• Adaptable for Any Device: Whether you’re manufacturing a Class I, IIa, IIb, or Class III medical device, active or non-active, invasive or non-invasive, this template is designed to accommodate any type of medical device and risk profile.
• Audit-Ready Documentation: Ensures that your risk management file is organized, transparent, and ready for regulatory audits, internal reviews, or notified body assessments.

What’s Included?

• Editable Template in Excel and Word format: A fully customizable document that can be tailored to your specific medical device and risk profile.
• Pre-Structured Sections: Covers all mandatory elements, including risk identification, analysis, control measures, and residual risk evaluation
• Guidance Notes: Step-by-step instructions and examples for completing each section of the risk management report.
• Traceability Matrix: Links identified risks to risk control measures, relevant documents and evidence, ensuring a clear risk management process.

Ensure Compliance with EU MDR & ISO 14971

Our Risk Management Report Template helps you document and manage risks throughout your device’s lifecycle, ensuring regulatory compliance with EU MDR 2017/745 and ISO 14971. By using this template, you can efficiently compile a comprehensive and audit-ready risk management report that meets the highest standards of safety and performance.