SOP Document Package

MDEL Quality System Documents

CliniEco Medical maintains a complete set of Standard Operating Procedures (SOPs) as part of our Medical Device Establishment License (MDEL) quality management system.

Documents Included

SOP Title Purpose Applied To
SOP-01 Complaint Handling Systematic process for receiving and investigating complaints All products
SOP-02 Recall Procedure Effective recall of medical devices that may present health risk Class I devices
SOP-03 Adverse Event Reporting Identification and reporting of adverse events to Health Canada Class I devices
SOP-04 Traceability System Product tracking from supplier through to end customer Class I devices
SOP-05 Document Control Quality document creation, review, approval, and maintenance All products
SOP-06 Supplier Management Supplier selection, evaluation, and ongoing monitoring Class I devices

Sample SOP Content

Each SOP includes: Purpose, Scope, Definitions (where applicable), Detailed Procedure, Record Retention requirements, and Regulatory References. SOPs reference Health Canada GUI-0016, GUI-0060, ISO 13485:2016, and SOR/98-282 Medical Devices Regulations.

Note: The full SOP document package is available upon request for MDEL audit purposes. Contact our quality team at info@clinieco.ca.