As some of you are aware, In Vitro Diagnostic Regulation (IVDR) will be effective May 2022. As this regulation has several new requirements, some simple and some complex.
Risk management is understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.
The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF
The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations.
Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations.
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device
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