February 9, 2023

[FREE WEBINAR] New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

Click here to watch the recording of this webinar.

The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe.  IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR. 

In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.   

Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers. 

Key Takeaways

  • What are the major changes from IVDD to IVDR?
  • How does IVDR define “Clinical Evidence,” and where can you find it?
  • What are the Notified Body’s expectations (and advice)?

Who Should Watch?

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

Who are the Panelists?

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

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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 

Sign up for future webinars here.


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September 13, 2022

MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers  

Author: Criterion Edge Writers

What You Need to Know  

The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.  

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