Have there been any serious accidents when using our products? (Non-conforming device, malfunction, failure, serious accident as defined by MEDDEV)
Have there been any non-serious accidents when using our products? (No impact on IVD performance, no impact on safety, health and sanitation, no impact on health and safety, no impact on health and safety. patient`s condition)
Have you experienced any side/adverse effects or lack of aids when using our products? If yes, please specify the situation. (For example, lack of identification, durability, reliability, safety, etc.)