CEP, CER and PSUR Consulting for a Global Medical Device Manufacturer​

Performed extensive literature searches for subject device and state of the art.

Updated the CEP/CER with the data each year for annual maintenance.

Came up with measurable benefits and endpoints and amend based on any new data.

Came up with safety and performance parameters for determining acceptability of benefit risk.

Determined the acceptance criteria for each parameter and benefit using data from State of the Art.

Updated the acceptance criteria based on new data availability.

Updated data relating to any new publications/ clinical studies/ PMCF data availability.

Conducted risk mapping of all events reported for subject and similar device in published literature, safety databases, manufacturer held data.

Facilitated review of the documents by a TA expert in line with the requirements of EU MDR.

Initiated annual maintenance activities as and when needed to align with the timelines and not deviate from SOPs as well as stated EU MDR requirements.

Provided finalized formatted word and PDF documents for signature and approval.