Risk Management
Managing risk is a regulatory obligation and a critical part of protecting patient health. For medical device manufacturers, implementing a risk management system aligned with ISO 14971 is essential to meet the requirements of authorities like Anvisa, FDA, and Notified Bodies in Europe.
If your company focuses on the Brazilian market, you need a structured Risk Analysis for safer, compliant medical devices.
At Sobel, we offer a complete Risk Management Service tailored to the needs of your device, your documentation status, and your target market. From process design to documentation review, we help your company build a solid risk management foundation, aligned with global expectations and local demands.
How We Support Your Risk Management Process
Implementing a risk management system that truly works—on paper and in practice—is a key part of getting your medical device approved.
At Sobel, we help you meet the ISO 14971 standard, making the process simpler, clearer, and fully adapted to your product and regulatory targets. Whether you’re starting from zero or improving existing documentation, our support is designed to give you confidence and compliance in every step.
We work with your team on:
Development of your Risk Management Procedure (SOP) in line with ISO 14971
Preparation of key documents: Risk Management Plan, Risk Analysis Form, and Risk Management Report
Review and critical analysis of existing documentation, identifying gaps in compliance with ISO 14971 and ANVISA requirements
Proposal of practical solutions to close compliance gaps
Creation of real-world examples based on your product to demonstrate application of the process
Expert guidance on integrating risk management with biological and toxicological risk assessment for ANVISA and other regulators
Training and technical support, so your team understands and implements the process correctly
Why do you need this service?
If you are preparing a risk management plan for Brazil, your documentation must align with ISO 14971 and satisfy Anvisa’s demands.
A complete medical device risk analysis helps identify, evaluate, and mitigate potential hazards—protecting users and enhancing product reliability.
Well-documented risk management procedures demonstrate due diligence and help reduce back-and-forth with agencies, saving time and avoiding costly delays.
With the right documentation and process in place, you reduce regulatory friction and bring safer products to market faster. By partnering with a highly qualified team like Sobel, you gain expert guidance that simplifies the complexities of the regulatory system.
Looking for Risk Management Assistance?
Whether you need to develop your documentation from scratch or review what you already have, Sobel provides expert guidance and practical tools to ensure your risk management complies with ISO 14971 and meets the standards of Anvisa.
Our team of experts is ready to collaborate with you to develop and implement a risk management process that ensures compliance and promotes patient safety.
Need help with medical device risk management in Brazil or beyond? Talk to Sobel and take the next step toward safer, compliant products.
