Supplier & Manufacturer Policy – Device Lifecycle, Maintenance & Regulatory Compliance

Supplier & Manufacturer Expectations

Supplier & Manufacturer Expectations – Device Lifecycle and Maintenance Transparency

As part of our commitment to safe, effective, and fiscally responsible clinical operations, IVONNE® requires that all medical device suppliers and manufacturers providing equipment or services to our clinic must:

1. Comply fully with the principles of applicable regulatory frameworks and quality management systems relevant to their jurisdiction and classification, including but not limited to:
   • U.S. FDA 21 CFR Part 820 (Quality System Regulation)
   • Health Canada Medical Devices Regulations (SOR/98-282)
   • Any applicable ISO certification(s) held by the supplier (e.g., ISO 13485:2016)
2. Provide comprehensive documentation for all devices and systems, including:
   • Preventive maintenance schedules (i.e., maintenance performed to mitigate degradation and reduce the probability of failure)
   • General maintenance procedures (i.e., technical and management actions intended to retain or restore performance)
   • Restoration procedures (i.e., actions to replace or repair defective components to restore function)
   • Inspection intervals and pass/fail criteria (i.e., conformity assessments with specified requirements)
   • Expected lifespan and replacement intervals for key components and consumables
   • Estimated timeline and cost range for each maintenance, inspection, and restoration action over the life of the device
3. Maintain version control and documentation integrity by:
   • Providing formal written notice to IVONNE® of any changes, updates, or additions to maintenance, inspection, restoration, or safety documentation
   • Clearly specifying where updated documentation may be accessed or retrieved
   • Ensuring that all outdated or superseded documentation is explicitly retired, removed, or marked as obsolete to avoid overlap or confusion
4. Self-report changes to regulatory requirements that may impact the operation, maintenance, servicing, or patient safety implications of their equipment within Canada, including but not limited to:
   • New or revised obligations under Health Canada, FDA, ISO, or other applicable jurisdictions
   • Any reclassification, advisory, warning, or enforcement action related to the device or its components
   • Clear notice outlining the implications for use, updated instructions, and any required modifications to clinical workflows or capital planning

These expectations support our internal Health Technology Management (HTM) systems and enable proactive capital budgeting for clinical equipment servicing and replacement, while ensuring that patient safety and regulatory compliance remain uncompromised.

Contact Information About This Policy

For any questions or complaints in relation to this agreement or any product or treatment you purchase, you may contact IVONNE at the following:

By Regular Mail:
IVONNE, Inc.
0116-320 Queen Street, Ottawa ON K1R 5A3

By Email:
17085726816adb64457db81

By Phone:
(613) 695-6662

By Social Media:
@ivonneclinic