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
Webinar: rSDV for Clin Ops efficiency & Cost Saving While on-site monitoring is one of the biggest cost drivers of clinical trial operations, Remote Source Document Verification (rSDV) offers.
Webinar: How effective is your CRO and Vendor Oversight Oversight is YOUR responsibility no matter what you outsource and to which vendors you work with. You are accountable fully in the eyes of healthcare regulators.