RISK MANAGEMENT

The outcomes and activities of the risk management process are documented within the Risk Management File (RMF). This file includes a collection of records and supporting documents generated at various stages, which may not be contiguous but collectively demonstrate compliance and thorough risk control.

Risk analysis is an ongoing activity that begins at the device’s design phase and continues throughout its production, post-market use, and eventual disposal, ensuring continuous safety and effectiveness.

Medical Device Risk Management Services

At RAPS, we provide expert support in preparing and managing your medical device risk analysis procedure in accordance with the latest harmonized standards, including ISO 14971. Our services include:

Review and Gap Analysis: We thoroughly review your existing risk management documentation to identify gaps, particularly in hazard identification, risk assessment, and mitigation strategies, and provide targeted updates to ensure completeness.
Hazard Identification: Proactively identifying new potential hazards that may arise during device use or lifecycle changes.
Comprehensive Documentation: We document all risk management activities—including planning, assessments, risk control effectiveness, and post-market surveillance—as part of the Risk Management File (RMF).
Residual Risk Evaluation: Performing risk-benefit analyses using manufacturer data and literature to demonstrate that the medical benefits outweigh any remaining residual risks.
Reporting and Conclusions: Preparing clear, regulatory-compliant risk management reports and conclusions.

As experienced risk management consultants with up-to-date regulatory knowledge, we help you maintain your RMF efficiently and support you in achieving certification faster.

Medical Device Risk Management Stages

Risk Management Plan
Establish a comprehensive risk management framework and assign responsible personnel for each phase of risk activities.
Risk Analysis
Systematically identify hazards and estimate associated risks.
Risk Evaluation
Assess the acceptability of the identified risks.
Risk Control
Implement measures to reduce risks to acceptable levels.
Risk Management Report
Document the entire process, findings, and decisions.

Medical Device Risk Analysis Process

Risk analysis involves a stepwise approach using available data to identify hazards and estimate risks during both normal use and fault conditions:

Intended Use and Safety Characteristics
Identify the device’s quantitative and qualitative safety-related features, including potential misuse scenarios.
Hazard Identification
Detect all possible hazards during normal operation and fault conditions.
Risk Estimation
Estimate the risk for each hazardous situation, applying qualitative or quantitative methods to determine probability and severity of harm.

Collaborative Risk Management

Effective risk management requires a cross-functional team with expertise from various disciplines. When necessary, top management may engage external consultants or specialists to complement internal resources and enhance risk management activities.

Effective medical device risk management is critical to ensuring product safety, regulatory compliance, and patient protection throughout the device lifecycle. By following a structured, standardized approach and leveraging expert support, manufacturers can confidently identify and control risks, minimize residual hazards, and accelerate certification processes. At RAPS, we are committed to guiding you every step of the way—helping you build a robust Risk Management File that meets the latest regulatory requirements and drives continuous improvement.

Medical Device Risk Management Report

RISK MANAGEMENT

Medical Device Risk Management Services

Medical Device Risk Management Stages

Medical Device Risk Analysis Process

Collaborative Risk Management

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