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Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4
Clinical Evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The evaluation is based on comprehensive analysis of pre-and post-market clinical data relevant to the intended use. This includes data specific to the device as well as any data relating to devices claimed as equivalent by the manufacturer. The whole process is documented in a clinical evaluation report (CER).
As per Chapter VI, Article 49, Clinical evaluation needed to demonstrate the safety and performance of the devices. NO MATTER whatever the class of the device
In short, the MEDDEV 2.7.1 Rev. 4, Clinical evaluation means the assessment and analysis of clinical data pertaining to a device to verify the safety and performance of the device
Safety and/or performance information that are generated from the use of a medical device. (This term is further explained in GHTF document SG5/N1R8:2007)
The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. (This term is further explained in GHTF document SG5/N1R8:2007)
The clinical data and the clinical evaluation report pertaining to a medical device. (This term is further explained in GHTF document SG5/N1R8:2007)How LMG can assist with the medical device Clinical Evaluation Report (CER)?
We review your IFU, RESIDUAL RISK, PMS and PMCF data initially followed by preparing a Clinical Evaluation Plan. Our team of consultant's draft procedure and relevant templets initially and will guide further in developing documents.
Our consultants also will ensure that your Clinical Evaluation Report (CER) meets all European requirements thereby build more confidence on Notified Body.
No matter where you are. We support to Global Medical Device fraternity via onsite visit, Cloud documentation, Skype video calling and emails.
LMG can assist you with
- Medical Device Classification
- Identification of MDD requirements
- Identification of Harmonized standards
- ISO 13485 Implementation
- Identification of Notified Body
- Technical File preparation
- Technical File submission to Notified Body
- Technical file re-submission
- Assistance with Notified Body audit
- Assistance in closing non-conformities
- Affix CE Mark