• We offer End-to-End CEP and CER writing services following MEDDEV 2.7/1 Rev.4 guidelines and Medical Device Regulation (MDR).
• We develop CEP and CER templates and tailored them as per client requirements.
• We prepare a GAP assessment checklist and perform GAP analysis for existing CER and provide recommendations following MEDDEV 2.7/1 Rev.4 guidelines and Medical Device Regulation (MDR).
• We can handle the periodic update of existing CER as per MEDDEV 2.7/1 Rev.4 guidelines and Medical Device Regulation (MDR).
• We present an in-depth clinical data analysis taken from clinical investigations and literature search results.
• We can provide Systematic Literature Review (SLR) services. Our Medical Information Specialists will design a comprehensive literature search protocol, with complete documentation of the literature screening and data extraction process. QC reviewers ensure the document is scientifically sound, accurate and adheres to current guidelines and client internal structure.
• We summarize the State of the Art background and maturity of current technology for your device.
• We can establish a strong Equivalence argument (if needed)
• We can provide clear summaries of Post Market Surveillance (PMS) data, Risk-Benefit analysis, and Post Market Clinical Follow-Up (PMCF).

Invitro Diagnostics

With our experienced medical writers:

• Technical documentation and declaration of conformity as per IVDR 2017/746
• We can develop Scientific validity reports, clinical performance reports, analytical performance reports, performance evaluation plan and performance evaluation reports