Medical Device Consulting

Expert Guidance

Production of medical device related documentation for MDD (93/42/EEC) remediation to MDR (EU 2017/745) 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 (SOTA) analysis
Risk, benefit and safety analysis
Use of reference manager software such as Endnote

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

Medical Device Consulting: Services