We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on 11 December 2018.
But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording.
In brief during the session, we discussed about decoding the step-wise approach for compliant Clinical Evaluation Report, inclusive of:
- CER- Industry Reception in last 2 years
- Clinical Data, Evaluation and Evidence - Overview
- PMS Data – Key Input for CER
- Clinical Evaluation - Key component for Clinical Evidence
- Key High Lights of MEDDEV 2.7/1 REV 4
- Clinical Evaluation Report- Key Characteristics
- Focus points for a “compliant CER”
- Stage wise approach for CER Authoring
- Key Impact Elements for CER Projects
- 4Q – Requirement consolidation
- Accelerators/ Enablers in CER Projects
- Next steps