PER Writing for a Blood Diagnostic Device
A global leader in the medical industry.
Project Scope
- Ownership for successful external Technical File audit
- Understanding of the device V&V testing data
- Executed from offshore to provide cost efficiencies
Project Deliverables
- The rationale for the frequency of the PER
- Analytical performance report (APR)
- Clinical performance report (CPR)
- Equivalence establishment
- Justification for the selection of equivalence and size for the testing
- Execute all the gaps identified
- Clinical performance studies
- Peer-reviewed published literature
- Experience gained through routine testing
- Content and structure of the Performance Evaluation Report (PER)
Key Tools
- Ovid MEDLINE®
- PubMed
- Scopus
- Google Scholar
