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Medical Device Vigilance

Lindeq takes care of your regulatory obligations

 

Besides topics like latest technology the compliance with regulatory affairs is a part of manufacturing medical devices as well. With the aim of minimising risks and to enhance safety and health of patients, users and third persons, the European Union has established several requirements that manufacturers have to be compliant with.
Medical device manufacturers are obliged to know, understand and to act in line with these EU regulations and to have a systematic procedure on place that reviews and updates gained experience from devices in the post production phase as well as submit vigilance reports to the respective competent authority if necessary.
Regulatory compliance requires a high degree of time and effort in order to have everything on place - all time. In Lindeq we are up-to-date with the EU medical device regulations to take care of your regulatory obligations and to save your time. Our medical device vigilance clients manufacture different types of devices and we support them in both, establishing and maintaining a medical device vigilance system.
Contact us to find out in which way we can support you with your medical device. Together we find out which tasks have to be done to be compliant in short time.
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