Google Scholar Integration - CAPTIS™ Features A crucial part of the Clinical Evaluation of Medical Devices and In-Vitro Diagnostic Devices under the EU MDR and IVDR are the Systematic Literature Reviews. In MEDDEV 2.7/1 rev 4 , the significance of a systematic review is constantly emphasized as being essential to ensure compliance with the

Data Dictionary - CAPTIS™ Features “…let me just transfer all this device information from the Clinical Evaluation Plan to the Clinical Evaluation Report template. Quite a few sections are the same.” Sounds familiar? The arrival of the EU MDR and IVDR introduced new reporting requirements for medical device manufacturers. If you’re a part of

PRISMA Flow Diagram - CAPTIS™ Features When writing Clinical Evaluation Reports (CERs), one of the core activities that take up the bulk of the total effort is the Systematic Literature Review. Systematic literature reviews are comprehensive and transparent, and typically conducted over multiple databases using a well-defined search and review strategy. You

Streamlined Systematic Literature Reviews CAPTIS™ is a ground-breaking solution for the RA/QA departments in the medical device industry looking to increase compliance and reduce the burden on their resources. Celegence’s CAPTIS™ software solution simplifies the process of writing PMS documentation for EU MDR and IVDR compliance. It allows medical writers to conduct systematic literature

CAPTIS Deep Dive - MDR & IVDR Compliance Technology While our CAPTIS EU MDR & IVDR Technology was only recently introduced to the industry, the Celegence medical writing team has been using the tool since 2020. When developing this technology, it was evident there were glaring gaps in the functionality of other literature