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: 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: 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.
Webinar: Next Generation of Central Monitor and Monitoring in RBM-Industry Updates
With the inclusion of centralized monitoring in risk based monitoring (RBM) approach; the Central Monitor is emerging as a key and important role.
Webinar: Strategies for Global Labeling Management in Changing Reg Environment
If you are part of Regulatory – Labeling team in your company, you should not miss this Webinar. As you are constantly working to coordinate a more robust end-to-end.
Webinar: Focusing Investigational Sites Risks in RBM
Sponsor’s performance of investigational site risk assessment is essential for effective planning and implementation of clinical trial project.
[wpcode id=”8392″]
