Medical Device Supplier Audit & Qualification

For medical device manufacturers, supplier performance directly impacts product quality, compliance, and audit readiness. A medical supplier audit is a key tool to verify whether critical suppliers operate in alignment with quality and regulatory expectations.

For who?

Sobel conducts structured medical supplier audits to help manufacturers gain visibility into supplier processes and identify potential compliance risks early.

Why do you need this service?

Supplier-related gaps are a frequent source of non-conformities during regulatory and certification audits.

Inadequate supplier oversight can compromise product quality, traceability, and regulatory compliance.

A structured supplier audit helps identify weaknesses early, supporting corrective actions before issues escalate.

Reduce supplier-related risk through structured audits.

Early identification of supplier-related gaps helps prevent downstream quality and regulatory issues. Sobel conducts structured supplier audits to support proactive supplier oversight.

Supplier audits designed for regulatory and quality assurance.

Scope alignment

We define the audit scope, applicable standard, and audit objectives, ensuring alignment with your supplier oversight needs.

Audit planning

An audit plan is prepared outlining activities, timelines, and documentation to be reviewed.

Procedural assessment

Supplier procedures are reviewed to assess structure, completeness, and alignment with quality and regulatory requirements.

Audit reporting

Audit results and any identified non-conformities are documented in a structured audit report.

Which service applies to your medical device?

Medical device licensing in Canada involves different obligations depending on your role, device class, and regulatory stage. Sobel offers modular services that can be contracted individually or combined, allowing you to engage the level of support that best matches your regulatory needs:

Medical Device Establishment Licence (MDEL) Application

Ideal for companies required to hold an establishment license in Canada, this service supports manufacturers, importers, and distributors in preparing and submitting the MDEL application. Sobel assists with the completion of the applicable form and supports communication with Health Canada.

Medical Device Licence (MDL) Application – Class II to IV

Designed for manufacturers applying for product-specific licensing, this service supports Class II, III, and IV medical device applications in Canada. Sobel assists with the preparation of the relevant application form and regulatory communication, helping align licensing activities with Health Canada requirements.

Full Package – Class II Medical Device Application

Best suited for manufacturers seeking comprehensive regulatory support, this package covers the full Class II application process. Sobel supports regulatory classification, application preparation, gap analysis, submission, and interaction with Health Canada.

Not sure how to register your medical device product with Anvisa?

Our role is to provide clarity, structure, and regulatory guidance while maintaining clear boundaries between consulting support and manufacturer responsibilities.

Related
Services

This service is ideal for manufacturers seeking an independent assessment of supplier quality and compliance without on-site activities. Sobel also supports manufacturers with:

Internal Audit Medical Device

Prepare your company for regulatory certifications with internal audit.

Medical Device License Support

Regulatory support for licensing applications and ongoing compliance.

Quality Management Support

Medical device quality management aligned with regulatory expectations.

Gain confidence in your supplier oversight strategy

Effective supplier oversight supports product quality and regulatory compliance. Sobel’s medical supplier audit services help manufacturers gain clarity, reduce risk, and strengthen supplier management within their quality systems.

Still have questions? Checkout our FAQ

1. What is a medical supplier audit?

A medical supplier audit is a structured evaluation of a supplier’s quality and regulatory processes to verify their adherence to agreed standards and the manufacturer’s quality system requirements, particularly for components or services critical to medical device production.

2. Why is supplier auditing important for medical device manufacturers in Canada?

Effective supplier oversight helps ensure that outsourced processes and materials consistently meet quality expectations and regulatory requirements, reducing compliance risks during regulatory or certification audits.

3. How does a supplier audit differ from an internal audit?

A supplier audit focuses specifically on the quality and compliance processes of external suppliers, while an internal audit assesses the manufacturer’s own quality management system. Both support regulatory readiness but address different scope areas, and Sobel provides internal audit services to support comprehensive quality oversight.

4. Can supplier audits help prepare for MDSAP or certification audits?

Yes. Supplier audits are often part of a broader audit strategy to demonstrate effective supplier control, which is a critical element of ISO 13485 and programs such as MDSAP that Canada uses for QMS compliance.

5. Will we receive documentation after the audit?

Yes. The audit includes a formal audit plan and a structured audit report summarizing results and any identified non-conformities.