Medical Device Consulting

Expert Guidance

Production of medical device related documentation for the MDD/MDR regulations including:​

• Clinical Evaluation Plans (CEPs) and Literature Reviews

• Clinical Evaluation Reports (CERs)

• FDA Maude database search and analysis

• Peer reviewed published study summaries and manufacturer held clinical study summaries

• State of the art analysis

• Risk, benefit and safety analysis

• Use of reference manager software such as Endnote

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Click 'Learn More' for additional literature search services including bespoke searches and article appraisal processes.