With MDR in effect, either developing or maintaining (annual updates) Clinical Evaluation Reports (CER) becomes an important activity for device manufacturers.
As a solution provider, MakroCare offers right strategy starting with Gap Analysis of your existing CER (if an Update is needed), all available data from clinical to safety to risk management to literature before arriving on right CEP. Based on the designed plan, next steps of execution are undertaken with right teams located globally to ensure scale, speed and quality.
MakroCare will assist you in completion of your PER projects in an efficient & compliant manner following Regulatory guidelines and Notified Bodies inputs.
Let's talk about how MakroCare can help you