Risk Management
Risk Management Services for Medical Devices
In the European Union, implementing a structured and well-documented risk management process is essential for achieving and maintaining CE marking under MDR 2017/745. Beyond regulatory obligation, it’s a critical part of delivering safe, high-quality medical devices.
To guide your company to achieve compliance, we offer specialized support in risk management for medical devices in Europe, helping you develop, review, and optimize your documentation in line with ISO 14971 and the expectations of Notified Bodies. Our approach combines technical depth with regulatory insight—so you stay compliant and focused on product safety.
How We Support Your Risk Management Process
Regulatory authorities and Notified Bodies expect evidence of a systematic, traceable risk management strategy. We help your team build or refine this process step by step, applying ISO 14971 in a way that meets EU expectations. Our service includes:
Critical review of your Risk Management Plan and Report to assess conformity with ISO 14971 and MDR
Identification of documentation gaps and actionable solutions for improvement
Creation or refinement of: Risk Management SOPs, Risk Analysis and Evaluation Forms, Risk Management Report
Support in preparing a risk file for Notified Bodies, with clarity, completeness, and traceability
Training on risk management activities, including: Hazard identification and assessment, Risk control implementation, Residual risk evaluation and benefit-risk analysis, Ongoing monitoring for post-market risk control
Guidance on how to apply ISO 14971 under EU MDR and integrate with your technical file
Why do you need this service?
We help ensure your process aligns with EU risk management compliance standards and withstands Notified Body review.
A solid CE marking risk assessment process reduces the chance of recalls, incidents, or clinical performance issues—strengthening your product’s reputation.
Clear, well-structured risk documentation accelerates review by Notified Bodies and reduces the likelihood of time-consuming revisions or objections.
With the right documentation, methodology, and strategic approach, your product enters the EU market with enhanced strength, safety, and full compliance, positioning it for long-term success.
Looking for Risk Management Assistance?
Navigating the complexities of risk management in the medical device sector requires expertise and precision. Our team is dedicated to guiding you through the ISO 14971 framework, ensuring your products not only comply with regulatory standards but also uphold the highest levels of safety and effectiveness.
Whether reviewing existing files or building from the ground up, we’re here to help.
