Webinar on Risk Management EU MDR Perspective

MC Webinar

Risk management is understood as a continuous iterative process throughout the entire life cycle of a device, requiring regular systematic updating. Though Risk management has been a requirement in MDD also, EU MDR places greater emphasize on this area. EU MDR has provided detailed description on how manufacturers should establish, document, implement and maintain a system for risk management. Risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the process of clinical risks that needs to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. Risk Management and clinical evaluation processes should be inter-dependent and should be frequently updated.

Considering the importance of risk management with EU MDR, this webinar is designed to focus on the following aspects of risk management in EU-MDR perspective.

  • Risk management requirement under MDR
  • Risk-Benefit analysis
  • Clinical Investigations under MDR
  • Expectations above and beyond MEDDEV 2.7.1, Rev 4
  • Conformity Assessment Procedures
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Webinar on Importance & Requirements of Clinical Evaluation for CER

MC CER Webinar

The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations. A sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient evidence to demonstrate conformity with relevant essential requirements for performance and safety is very critical. The demonstration of “equivalence” between subject device and predicate is much stricter now and may lead to requirement of generating more clinical data with larger patient populations. The importance of an overall evaluation of the device needs to be emphasized with particular focus on ensuring that clinical data are evaluated in a systematic and objective way, that the benefit/risk profile is acceptable and any knowledge gaps are identified and addressed. Considering the importance & requirement of clinical evaluation for CER writing and updating, this webinar is planned to focus on the following aspects.

  • 5 stages of Clinical evaluation
  • New Requirements for justifying Equivalence
  • PMS & PMCF
  • Qualifications of the Evaluators
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Webinar on Growing need of Clinical Data, PMCF & Registries for Devices

 

FB-Webinar-Nov-15

Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps surrounding past PMCF work are becoming more evident. “Passive” collection of adverse events, complaints and the like may not be sufficient any longer to demonstrate conformity to the Essential Requirements and to the future Medical Device Regulation (MDR). This webinar will review emerging PMCF, Registry needs in this era of pre-MDR business risk evaluations.

Learning objectives:

Tick Bullet Clearly define PMCF, Registry needs for Devices

Tick Bullet Apply CER gaps in safety and performance clinical data to PMCF & registry designs

Tick Bullet Differentiate adequate PMCF plans from less than adequate PMCF plans

Tick Bullet Alternate methods of getting Clinical data for your Devices

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Webinar on Explore 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 the best alternative to significantly reduce onsite monitoring activities to build efficiencies, data quality and assure human subject protection.

This webinar will explore the differences between rSDV and other monitoring methods, how to maintain subject privacy in the process of collecting source documents and what 21 CFR Part 11 requires, strategies for remote review of source documents at sites that do not utilize electronic medical records. Explore the great benefits of rSDV and for the types of studies it can be leveraged in a big way.

This webinar covers:

  • Remote Source Document Verification (rSDV) process
  • Strategies & challenges in implementing rSDV
  • Benefits of rSDV
  • Subject confidentiality & 21 CFR Part 11 requirements
  • CRA compliance in remote setting

Speaker Details:

Laura LaRosa, RN MS
Quality Management Strategist &
Investigative Compliance specialist

Date & Time:

Tuesday, 27th June
11 AM -12 Noon EST
5 PM – 6 PM CET

For further details mail us at webinar@makrocare.com

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