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Webinar
Webinar: EU IVDR Performance Evaluation, Data Requirements & Gaps
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.
Webinar: Risk Management EU MDR Perspective
Risk management is understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.
Webinar: Medical Device PMS & PMCF: Challenges & Opportunities
The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF
Webinar: Importance & Requirements of Clinical Evaluation for CER
The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations.
Webinar: Growing need of Clinical Data, PMCF & Registries for Devices
Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations.
Webinar: Device Compliance with MEDDEV 2.7.1 Rev 4 for Clin Eval / CER
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device
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