2022 for IVDR compliance is not far, though it gives a perception of “enough time” Based on the risk class, requirements for clinical evidence increase to support the safety and performance of your products Performance Evaluation From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and […]
MakroCare offers right strategy starting with Gap Analysis of your existing Clinical evaluation report(CER) (if an Update is needed), all available data from clinical to safety to risk management to literature before arriving on right Clinical evaluation performance(CEP). Based on the designed plan, next steps of execution are undertaken with right teams located globally to ensure scale, speed and quality.