November 5, 2022

[FREE WEBINAR] Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

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In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products, biocides, and personal protective equipment, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment.

In this “Critical Concepts” webinar, we discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16.

Key Takeaways

  • Learn the potential impact of risk-based classifications on your data collection strategies
  • Understand how to support data sufficiency in the CER and PER
  • Gain best-practice strategies for device classification

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

President Laurie Mitchell 

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October 31, 2022

[FREE WEBINAR] Critical Concepts: The Role of Post Market Activities in Establishing Data Sufficiency

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In this webinar, we review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to help you harness the potential of effective post market activities.

We discuss how legacy devices, defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. 

Key Takeaways

  • Learn which types of clinical data are appropriate to use for legacy devices
  • How to effectively identify, present and analyze clinical data for both MDR and IVDR requirements
  • Understand the MDCG 2020-6 guidance on clinical data for legacy devices

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for IVDR or MDR submissions.  

Who are the Panelists?

Stacie Beecham and Dr. Sarah Chavez

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September 30, 2022

[FREE WEBINAR] CER Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis

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Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to define safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio related to the CER. Our experts discuss how to develop MDR-aligned safety and performance objectives, how clinical outcomes are leveraged, and tie it all together in the Risk-Benefit section of the CER.

Key Takeaways

  • How to effectively identify, present and analyze CER parameters
  • Understand how clinical outcomes differentiate from S&P objectives
  • Learn how these key foundational concepts “tell the story” of the CER

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

President Laurie Mitchell 

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September 3, 2022

[FREE WEBINAR] Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

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How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. 

Key Takeaways

  • How to address limited clinical and performance data
  • Learn how to adjust the Clinical Evaluation Plan to align with the regulatory strategy
  • Understand the concept of data sufficiency

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

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August 8, 2022

[FREE WEBINAR] Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs 

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What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we discuss the concept of data sufficiency. Specifically, we explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer’s perspective. 

Key Takeaways

  • Learn what is deemed sufficient clinical data for certain device groups
  • Determine how to establish a legacy device as a ‘standard of care’ device
  • Understand the conformity assessment pathways for well-established technology devices

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD & Scientific Writing Services 

Stacie Beecham, Principal Medical Writer 

Sign up for future webinars here.


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