Product safety
Vigilance
Pharmacovigilance
We create the best possible safety for your medical device so that liability does not arise in the first place. However, damage to or caused by the product is always a possible outcome. In this case, you are on the safe side: as a legal manufacturer, we assume liability for your medical device and take care of vigilance or pharmacovigilance.
How do we assume your product liability?
As your legal manufacturer I Full service
Liability for a medical device is assumed by the legal manufacturer, as stipulated by law. We naturally fulfill this obligation when we represent you as the legal manufacturer. If the worst comes to the worst, we assume responsibility. No ifs, ands or buts.
As your consultant I Customized service
Of course, we can also advise you on regulatory requirements. What questions do you have about product liability for your medical device? Let us consider together how you can create the best possible product safety – so that there is no liability case in the first place.
There is something to report: Vigilance and pharmacovigilance
A report needs to be made because there has been an incident with your medical device? Leave that to us too.
Because our services as a legal manufacturer also include the vigilance or pharmacovigilance of your product. We systematically report incidents to the individual local authorities and ensure compliance with all regulatory requirements.
This allows you to meet the safety requirements for patients and users under the Medical Device Regulation (MDR) – without any additional effort.
Are you looking for a partner to protect you in the event of an emergency? Or do you need advice from our experts on the subject of liability for your medical device? Simply contact us without obligation and talk to us about your concerns.