Overview
This SOP outlines the procedures for managing feedback and responding to customer complaints effectively.
| Process Owner | \ |
| Key Performance Indicators | \ |
Regulatory References
| Regulation/Standard | Relevant Sections |
|---|---|
| Regulation 2017/745 (MDR) | Articles 83-88 (Post-market surveillance, trend analysis, and vigilance) |
| ISO 13485:2016 | Sections 8.2.1 / 8.2.2 |
| IEC 62304:2006 | Section 6.2.1 |
General Guidelines
This section should describe how your organization manages feedback and complaints. Include details on:
- Customer support availability (e.g., Mon-Fri, 9 AM-5 PM CET).
- Ticketing system (consider GDPR compliance for sensitive data).
- Primary contact channels (e.g., support email or phone).
- Response prioritization (e.g., high, medium, or low urgency).
- Preferred feedback response method (matching the channel of inquiry where feasible).
Feedback Categories
All feedback is categorized as follows. For unclear cases, the Operations team consults the Quality Management Officer (QMO).
| Category | Description |
|---|---|
| Support Inquiry | Requests for help resolved by providing additional information or guidance. |
| Change Request | Requests to add, modify, or remove product features. |
| Customer Complaint | Complaints relating to the product or organization that do not involve potential harm to patient health. |
| Health Impact Issue | Complaints involving device-related issues that could cause, may have caused, or have caused death, serious health deterioration, or impaired device performance based on intended use or related documentation. |
Definition of Serious Health Deterioration
A “serious deterioration of health” includes one or more of the following:
- A life-threatening illness.
- Permanent damage to body structure or function.
- Conditions requiring medical or surgical intervention to prevent life-threatening or permanent impairment.
- Indirect harm due to incorrect diagnostic results within intended use.
Process Workflow
1. Feedback Documentation
The Operations team captures all received feedback through designated channels, which automatically create tickets in the tracking system. The team records the following:
- Date of feedback.
- Issue description (e.g., software version, environment details, screenshots, etc.).
- Affected users, contact details, and locations.
- Steps to replicate the issue, if applicable.
| Participants | Operations team |
| Input | Received feedback |
| Output | Detailed ticket documentation |
2. Feedback Evaluation
The Operations team classifies the feedback as per the defined categories and takes corresponding actions:
Support Inquiry:
Provide necessary support or additional training to resolve the issue.
Change Request:
Forward to the Product team for assessment, potential implementation, and initiation of change management if needed.
Customer Complaint:
– For unresolved product issues (e.g., software bugs), forward to the Product team for resolution.
– For organizational issues (e.g., sales complaints), involve relevant departments.
– Escalate systematic issues to the QMO for corrective/preventive actions (CAPA).
Health Impact Issue:
Immediately notify the Person Responsible for Regulatory Compliance (PRRC) on the same day to initiate the SOP for Vigilance. Additionally, check for potential impacts on:
- Product requirements.
- Post-market surveillance and trend analysis (MDR Articles 83 and 88).
- Device risk management documentation.
| Participants | Operations team |
| Input | Documented feedback |
| Output | Categorized feedback with action decisions |
3. Validation of Actions
The Operations team monitors progress on ticket-related actions. Once resolved, they validate the solution with the customer/user and document the outcome in the system. If unresolved or the customer doesn’t respond, follow up before closing the ticket.
| Participants | Operations team |
| Input | Resolved actions |
| Output | Ticket closure with validation notes |
Optionally, you can implement a status-tracking system for tickets (e.g., Open, Pending Input, Closed).
Additional Considerations
Ensure feedback handling processes align with GDPR requirements and other relevant regulations. Maintain transparency in communication channels and update customers/users on actions promptly.