Article Index

Risk Management EU MDR
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.

Medical Device PMS PMCF
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.

CRO Vendor Oversight
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.