Internal Audit for Medical Devices

An effective internal audit medical device program helps verify whether quality procedures are clearly defined, properly implemented, and maintained. Sobel conducts structured audits that bring visibility to compliance and operational performance.

For who?

Internal audits play a critical role in identifying gaps, supporting compliance, and strengthening regulatory and quality readiness.

Why do you need this service?

Internal audits are a mandatory requirement under ISO 13485 for medical device quality management systems.

Gaps between documented procedures and actual implementation often remain unnoticed without independent audit review.

A structured internal audit helps identify non-conformities early, reducing regulatory, certification, and operational risks.

Turn documented procedures into verified practice

Sobel conducts internal audits through a structured and transparent approach, adapted to remote or on-site execution, with clear focus on objective evidence, traceability, and documented outcomes.

Internal audit medical device services designed to support compliance and readiness.

Audit scope alignment

We align the audit scope based on the applicable standard, audit objectives, and execution format, ensuring clarity on expectations, timelines, and responsibilities.

Procedural assessment

Documented procedures are reviewed to assess structure, completeness, and alignment with regulatory and standard requirements.

Operational verification

The practical application of procedures is assessed through objective evidence, confirming whether processes are effectively implemented within the organization.

Audit Report

Audit results, observations, and any identified non-conformities are consolidated into a clear and 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

Sobel’s internal audit services are designed to assess both procedural compliance and practical implementation. You can also count on our team to:

Gap Analysis

Submission Readiness and Label Review for Medical Devices.

Supplier Auditn

Improve supplier control through structured audit services.

Quality Management Support

Medical device quality management aligned with regulatory expectations.

Strengthen your quality system through medical device internal audits

A well-executed internal audit medical device process supports continuous improvement and regulatory confidence. We provide structured internal audit services to help manufacturers understand system performance and prepare for regulatory and certification expectations. Build confidence in your internal audit process with Sobel!

Still have questions? Checkout our FAQ

1. Are internal audits mandatory for medical device manufacturers in Canada?

Yes. Medical device manufacturers in Canada are required to maintain an ISO 13485–compliant quality management system, and internal audits are a mandatory requirement under ISO 13485, which is enforced through the Canadian regulatory framework.

2. How do internal audits support compliance with Health Canada requirements?

Internal audits help verify whether documented procedures are properly implemented and maintained, supporting ongoing compliance and preparedness for regulatory inspections and certification audits required by Health Canada.

3. Which standards can be used as the basis for the internal audit?

Internal audits are conducted based on the applicable standard agreed with the client, such as ISO 13485 or other relevant regulatory or quality standards.

4. Is the internal audit suitable for companies preparing for MDSAP audits?

Yes. Internal audits are commonly used to assess readiness for MDSAP audits by identifying gaps and implementation issues before external audits.

5. Will we receive formal documentation after the audit?

Yes. Each internal audit includes an audit plan and a structured audit report summarizing findings, observations, and any identified non-conformities.