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Vigilance & Product Safety Reporting

At SP Medical, patient safety is our highest priority.

If you become aware of an incident, product complaint, malfunction, or any event involving an SP Medical device that may have led to, or could potentially lead to, harm to a patient, user, or other person, please contact us immediately.

How to Report an Incident or Product Complaint

To ensure prompt and accurate handling, please submit all product complaints and vigilance reports by email and include as much information as possible about the device, the incident, and the circumstances in which it occurred. The more information you can provide, the better we can evaluate the event, assess any associated risks, and determine the appropriate course of action.

Email: GWComplaints@sp-medical.dk

Our Quality & Regulatory Affairs team reviews all reports and ensures appropriate investigation and follow-up actions in accordance with applicable regulatory requirements.

Urgent Product Safety Issues

For incidents involving serious injury, potential serious injury, or situations requiring immediate attention outside normal business hours, please contact us by telephone after submitting your email report.

Please note that this number should only be used for urgent product safety matters requiring immediate attention. For all other complaints and inquiries, please use the email address above.

We will respond as quickly as possible and initiate the appropriate escalation process.