Risk Management
When it comes to Health Canada, demonstrating robust risk management isn’t optional—it’s a regulatory necessity. Your device must not only function as intended but also prove, through structured analysis, that potential risks have been identified, evaluated, and controlled in accordance with ISO 14971.
You can have a complete risk management support for medical devices in Canada, helping your team navigate documentation, process gaps, and regulatory expectations. From plan development to critical review, we make risk management both manageable and meaningful.
How We Support Your Risk Management Process
Risk management is a key expectation in any Health Canada submission, and aligning with ISO 14971 is considered industry best practice. At Sobel, we support your team by reviewing and strengthening your existing documentation, identifying gaps, and helping you meet regulatory expectations through clear, structured risk analysis.
Here’s what we offer:
Critical review of your Risk Management Plan and Risk Management Report to assess compliance with ISO 14971
Identification of documentation gaps based on Health Canada expectations and ISO standards
Development of risk documentation: SOPs, Risk Analysis Forms, and Report templates
Real-case examples based on your product to show practical application of the standard
Training sessions on ISO 14971 and Canadian regulatory context
Guidance on integrating risk analysis into Canadian licensing submissions
Support in aligning your documentation with Health Canada’s safety and risk evidence requirements
Why do you need this service?
We help to verify that your risk management documentation complies with ISO 14971 and aligns with Health Canada’s licensing requirements.
Our structured risk assessment process helps demonstrate that your device’s risks are well understood, mitigated, and justified—building a solid case for approval.
A well-documented process adds value at every level—from product development to regulatory inspection—supporting both team efficiency and external credibility.
Managing risk effectively is a strategic advantage. With a compliant, well-documented risk management process in place, your device moves through Health Canada’s review with stronger evidence, greater clarity, and a safer profile.
With Sobel by your side, risk management becomes an integral part of your product development—not an afterthought. We work with you to make compliance feel effortless, empowering your team to focus on what matters most: creating safe, effective medical devices that improve lives.
Need Risk Management Assistance?
If you’re unsure about the adequacy of your current risk management process, let us help. Our team will conduct a detailed review of your Risk Management Plan and Report, identify any gaps, and provide actionable recommendations to ensure your documentation meets all necessary standards.
Let us help you structure your ISO 14971 risk management process for Canadian regulatory success, so your devices are safe, compliant, and ready for the global market.
