In Vitro Diagnostics Consulting

Expert Guidance

Imminent delivery of IVD Regulation (EU) 2017/746 related regulatory documentation including:

• Analytical Performance Reports (APR)

• Scientific Validity Reports (SVR)

• Clinical Performance Reports (CPR)

• Performance Evaluation Plan (PEP)

• General Safety & Performance Requirements (GSPR)

• Technical File Index (TFI)

• Summary of Safety & Performance (SSP)

• Postmarket Performance Follow Up Plan/Postmarket Surveillance Plan (PMPFP/PMSP)

• Gap Analysis