Regulatory Support
The Canadian regulatory landscape for medical devices requires precision, consistency, and a deep understanding of Health Canada’s evolving requirements. Whether you’re preparing for market entry or managing post-market obligations, having the right strategy is essential.
To guide your company, we offer specialized Regulatory Services in Canada, helping manufacturers comply with SOR/98-282 for medical devices.
From gap analysis to monthly regulatory support, we support your team through each step with clarity and confidence.
How We Help You Stay Compliant in Canada
Regulatory Services include evaluating product documentation, managing technical files, responding to regulatory inquiries, and maintaining alignment with Canadian regulations. Our approach is hands-on and tailored to your product type and business model.
Here’s how Sobel helps you stay compliant:
Perform a detailed regulatory gap analysis of your documentation, identifying areas for improvement
Compile technical documentation chapters according to Health Canada’s structure and requirements
Provide guidance for document revisions, including one included round of updates
Support your team with responses to regulatory inquiries and review comments
Maintain ongoing communication through our project management platform
Proactively monitor regulatory changes and notify your team of updates impacting your product
Offer on-demand regulatory affairs support
Why do you need this service?
Regulatory missteps can lead to product holds, penalties, or even removal from the market. We help you avoid costly errors through proactive support.
Our team brings specialized experience to help you prepare compliant technical files, respond to Health Canada inquiries, and maintain conformity throughout the product lifecycle.
Your team shouldn’t have to stop everything to deal with regulatory demands. We handle the complexity, so you can stay focused on innovation and growth.
A proactive regulatory approach is essential to operate smoothly and competitively in the Canadian market.
Your team doesn’t need to get buried in regulatory bureaucracy to succeed in the Canadian market. By partnering with Sobel, you gain direct access to a team of specialists who handle the complexities for you—so you can stay focused on your core business while we take care of compliance.
With the right support, your team can manage compliance confidently—without losing sight of your business priorities.
Need Help with Regulatory Affairs in Canada?
From documentation to strategy, SOBEL Consultancy delivers Regulatory Compliance Services that align with Canadian requirements—helping you launch and grow without unnecessary delays.
Let’s work together to keep your medical devices fully compliant, today and in the future.
