Compliance with the Medical Device Directive, and in the near future the Medical Device Regulation, is vital to be able to obtain and/or maintain CE-marking. Performing a clinical study is a serious and costly undertaking for every medical device manufacturer, requiring a strategic and practical approach.

Aqlivia has years of experience in regulatory affairs. Aqlivia CRO offers you the same, high level of expertise in clinical affairs. We support all kinds of trials for Class I Class III medical devices, to help you collect high quality, ISO14155, compliant clinical data. Our services include Clinical Strategy, Study start up, Monitoring, Data Management, Auditing, Training, Medical Writing, EC/CA/IRB communication, Project Management.

We truly believe in a strategic, notified body proof and overall practical approach. Setting-up clinical trials tailored to your medical device specific needs.
Aqlivia dedicated and experienced in all kinds of indications including urology, neurology, dental, cardiovascular, orthopedics, ophthalmology, imaging, etc. Our clinical team gained experience working at Notified Bodies, CRO’s and Sponsors/Manufacturers. This combination of different backgrounds, combined with Aqlivia’s in-depth knowledge of regulatory affair creates efficient and compliant clinical trials. Our expertise includes feasibility, pre-CE and post-market studies from class I to class III.
Because of our regulatory expertise, we are able to provide our practical approach, leading to tailored trials.