Medical-Device QMS & ISO Support
Support for ISO 13485, ISO 9001 and ISO 14971, including QMS development, gap assessments, SOPs, document control, CAPA, supplier quality and certification readiness.
Discuss your needs →Quality systems for safer products
Quality systems that work in practice.
Remote quality-management, auditing, and medical-device regulatory support for organizations worldwide.
ISO 9001ISO 13485ISO 14971Internal AuditsRegulatory Readiness
Practical support.
Clear outcomes.
QMS North helps medical-device organizations build, strengthen, and demonstrate effective quality systems that meet global regulatory requirements and support real-world operations.
Our services
Quality and regulatory support for the medical-device industry.
Focused assistance for small manufacturers, importers, distributors, clinics, and service providers—delivered remotely or on site where appropriate.
Internal Audits & Inspection Readiness
Remote and on-site internal audits, gap assessments, supplier audits, CAPA support, and preparation for customer, certification and regulatory inspections.
Prepare with confidence →
Global Regulatory & Canadian Compliance
International regulatory support with specialized Canadian expertise in MDEL obligations, complaints, mandatory problem reporting, recalls, distribution records, importer and distributor responsibilities, and Health Canada inspections.
Explore compliance support →A practical, risk-based approach
Structured support that fits your organization.
Every engagement is tailored to your products, markets, business stage and regulatory risk profile.
1UnderstandLearn about your organization, products and obligations.
2AssessIdentify gaps, risks and practical priorities.
3ImproveDevelop and implement sustainable solutions.
4SustainBuild on progress with ongoing support.
A stronger
quality system
quality system
Understand
Assess
Improve
Sustain
Experience that makes a difference
Medical-device quality expertise backed by more than 15 years of experience.
QMS North is supported by a professional team with extensive experience across medical-device quality systems, regulatory compliance, auditing, distribution, installation, servicing and post-market processes.
15+
years of practical experience
connecting regulatory requirements with the realities of everyday operations.
Medical-Device Focus
Deep experience in quality systems, regulatory requirements and product-lifecycle support.
Independent & Practical
Objective, risk-based solutions shaped around your organization—not generic templates.
International Support
Remote collaboration worldwide with specialized knowledge of Canadian requirements.
Get in touch
Let’s strengthen your quality system.
Tell us about your organization, current challenge, or upcoming audit. We’ll start with a focused conversation about where QMS North can help.
- Toronto, Canada
- contact@qmsnorth.com
- Connect on LinkedIn