MEDDEV 2.7/1 Revision 4, Annex 5, Section 3 of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) outlines methods for setting up the literature review screening guideline. This part of the EU MDR protocol is critical in demonstrating to auditors that medical device manufacturers are following a robust and repeatable process and can justify the inclusion or exclusion of specific data.
Duplicate literature references, transcription errors, and data entry errors can skew, or even invalidate, your results. DistillerSR provides built-in automation and validation tools that dramatically reduce the potential for errors in your clinical review process.
DistillerSR tracks all review activity and makes it easy to view the provenance of every cell of data. When your Notified Body comes to ask about your clinical evaluation report or performance evaluation report , DistillerSR can help you with capabilities such as a detailed audit log, data version control, and quick searching and lookup capabilities. Simply put, it effectively tracks all activity from your literature review protocol and process so that you don’t need to do it manually.