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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

Risk management


Risk management is a fundamental component of the regulatory approval process for medical devices and is a critical aspect of ensuring patient safety and compliance with regulatory requirements. It is an ongoing process directed at identifying and addressing potential risks throughout the entire lifecycle of the medical device.



The risk management process involves the following key steps

1. Risk Identification Identifying and documenting poten- tial hazards and risks associated with the medical device and its intended use. This includes analysing possible failure modes, harm- ful events, and poten- tial consequences. 2. Risk Evaluation Assessing the severity of identified risks and the likelihood of those risks occurring. This evaluation helps prioritise risks based on their potential impact on patient safety and device performance. 3. Risk Control Implementing measures to reduce or control identified risks to an acceptable level. This may involve design modifications, safety features, warning labels, or changes in the device's instructions for use 4. Risk Benefit Analysis Balancing the potential benefits of the medical device against its identified risks to determine if the overall benefit-risk profile is favorable

Ensuring ISO 14971 Compliance


Obtaining CE-marking for your medical devices is a critical milestone for market access in the European Union. To achieve this, a robust risk management system that aligns with ISO 14971 standards is of utmost importance.


Regulatory authorities in the EU place significant emphasis on risk management when assessing medical devices for CE-marking. A well-documented and ISO 14971 compliant risk management system can expedite the CE-marking process by providing a comprehensive and transparent overview of how your organisation addresses potential risks.

Let us support you in developing an ISO 14971 compliant risk management system that sets you on the path to success in the medical device industry.

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info@mdrc-services.com

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