Quality Management Support
MDSAP Compliance Support: achieve audit-ready compliance and unlock the Canadian Market with Sobel!
For manufacturers of Class II, III, and IV medical devices, aligning with MDSAP Health Canada requirements is essential. The Medical Device Single Audit Program (MDSAP) requires full compliance with ISO 13485, in addition to Canadian-specific quality requirements under CMDR (SOR-98/282).
This is why we provide expert-driven Quality Management Support to help you meet MDSAP requirements efficiently. From documentation review to internal audits, we guide you through every step with precision and clarity.
How We Support Your Path to MDSAP Certification
Our services are designed to help you build and maintain a compliant Quality Management System (QMS) that aligns with MDSAP, ISO 13485:2016, and Canadian regulations.
We can start with a complete gap assessment of your existing QMS:
Review of your Quality Manual and procedures against ISO 13485, SOR-98/282, and MDSAP requirements
Identification of non-conformities or missing elements
Delivery of a gap assessment report with clear, actionable guidance for improvements (including one document revision)
Based on the analysis, we can help bring your QMS into full alignment:
Drafting and revising QMS procedures and manuals
Structuring documentation in line with FDA MDSAP audit approach
Guidance on integrating ISO 9001 principles for a stronger Quality Management System
We can also perform an internal audit tailored to MDSAP:
Evaluation of your documented procedures for completeness and conformity
Verification of implementation across your operations
Final audit report summarizing findings and identifying non-conformities
Guidance on corrective actions to close gaps
Getting certified is the final step—we can help you get there confidently:
Pre-certification readiness check
Support in preparing for the official MDSAP audit
Ongoing consulting to maintain compliance and respond to future updates
Why do you need this service?
Health Canada only accepts MDSAP audits as proof of compliance for Class II, III, and IV medical devices. Without certification, your product can’t be registered or sold.
Our internal audit process highlights weaknesses early, so you can correct them before the official audit—reducing the risk of costly delays or non-compliance findings.
With targeted support, you won’t waste time or money on unnecessary procedures. We focus on what’s actually required—nothing more, nothing less.
Even though MDSAP is not ISO 9001, the principles of a well-structured ISO 9001 Quality Management System can enhance the effectiveness of your ISO 13485 implementation—and we help bridge those best practices.
With this partnership you build a stronger, long-term QMS.
Looking for MDSAP Support?
Let’s get your QMS MDSAP-Ready, together!
At Sobel, we combine practical experience with regulatory expertise to make MDSAP compliance achievable, not overwhelming. Whether you’re building your QMS from the ground up or just need help passing your audit, we’re here to support you every step of the way.
