Medical device quality management is a regulatory requirement for manufacturers seeking access to the Canadian market. Sobel supports manufacturers in aligning their quality systems with MDSAP, ISO 13485, and Health Canada requirements.
Without a compliant quality management system, products cannot be licensed, audited, or maintained under Canadian regulations.
Medical device manufacturers cannot access or maintain the Canadian market without demonstrating compliance with MDSAP requirements.
Gaps in quality management systems often result in audit findings, certification delays, or regulatory restrictions.
Structured quality management support helps manufacturers focus on what is truly required under MDSAP and ISO 13485.
Sobel’s quality management services are designed to assess, align, and strengthen your quality system without taking over manufacturer responsibilities.
Sobel supports manufacturers by strengthening medical device quality management systems aligned with Health Canada, helping organizations achieve and maintain MDSAP readiness with clarity and structure.
This service is ideal for manufacturers that already maintain an ISO 13485:2016–compliant quality management system. Sobel reviews the Quality Manual and Quality Procedures against Canadian regulatory requirements (SOR-98/282) and MDSAP expectations, identifying gaps and providing structured guidance to support document revisions and alignment.
Designed for manufacturers without an established ISO 13485:2016–aligned QMS, this service focuses on reviewing existing quality documentation against ISO 13485, MDSAP, and Canadian regulatory requirements. Sobel identifies gaps and provides guidance to support the necessary adjustments, helping organizations move toward a compliant quality framework.
This service supports a critical review of the existing risk management process, including the Risk Management Plan and Report. Sobel evaluates alignment with applicable standards, identifies gaps, and provides documented recommendations to strengthen the risk management approach.
Ongoing quality management support through written responses to day-to-day questions submitted via Sobel’s project management platform. It is designed to support routine quality and regulatory clarification.
Our role is to provide regulatory clarity, structured guidance, and objective insight to support sustainable compliance with Canadian requirements.
Medical device quality management supports the full product lifecycle and is closely linked to other regulatory and quality services. Sobel can help you with:
Sobel helps manufacturers strengthen their quality systems with structured, practical, and regulation-driven support. Talk to our team and strengthen your medical device quality management strategy for MDSAP compliance!
1. What is medical device quality management in Canada?
Medical device quality management refers to maintaining a quality management system (QMS) aligned with ISO 13485 and Canadian regulatory requirements, as required for Class II, III, and IV medical devices marketed in Canada.
2. Is MDSAP mandatory for medical devices in Canada?
Yes. For Class II, III, and IV medical devices, Health Canada accepts MDSAP audits as the required evidence of quality system compliance.
3. What is the difference between QMS adequation with and without ISO 13485 already available?
When ISO 13485 is already available, the service focuses on aligning an existing QMS with MDSAP and Canadian requirements. When ISO 13485 is not available, the service reviews existing quality documentation against ISO 13485, MDSAP, and Canadian regulations to identify gaps and guide alignment.
4. Can these services help prepare for an upcoming MDSAP audit?
Yes. Quality management reviews and gap assessments are commonly used to identify weaknesses and improve readiness before an official MDSAP audit.
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