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 

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June 16, 2022

[FREE WEBINAR] The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success 

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Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables, this presentation examines key drivers of project success, such as early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, and how to identify potential roadblocks and proactively find solutions to common problems.   

Key Takeaways

  • Identify critical components of the clinical evaluation process that influence project success. 
  • Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process. 
  • Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission.

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 or performance evaluation reports for IVDR submissions.

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

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June 2, 2022

[FREE WEBINAR] Scoping Your MDR and IVDR Writing Projects – The Forgotten Step

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In most of our webinars, we’ve focused on the writing process like which steps to take, and how to organize your thoughts onto paper. But we’ve never discussed what happens before the writing process begins. So what do you need before you get started?   

In this webinar, we discuss the process of scoping a writing project for either MDR or IVDR. What are the key questions we ask our clients before we start writing and what are the key inputs that are necessary to kickstart the project and ensure you’re starting on the right foot?  

Key Takeaways

  • Planning realistic timelines and assessing your team’s bandwidth to complete this project 
  • Examples of key documents and inputs needed early in the writing process 
  • Describe where these pieces fit within the CER or PER templates 

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 or Performance Evaluation Reports for IVDR submissions.

Who are the Panelists?

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

Laurie Mitchell, President | Criterion Edge

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May 19, 2022

[FREE WEBINAR] Ask the Writers: A Comparison of Critical Elements of the SVR vs. the CER State-of-the-Art and Best Practice Writing Strategies

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In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR). 

Key Takeaways

  • Understand the required and critical content common to both documents
  • Learn best-practice writing strategies to support successful completion of these challenging projects

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 or Scientific Validity Reports for IVDR submissions.

Who are the Panelists?

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

Laurie Mitchell, President | Criterion Edge

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April 21, 2022

[FREE WEBINAR] Establish the Competitive Landscape within the SVR

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In this practical presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). You will learn how to distinguish between the purpose and scope of the SOA search and the competitor search, in terms of the SLR approach, data screening, and data presentation

Key Takeaways

  • The importance of the SOA SLR for providing background and general information 
  • How data will be used to establish acceptance criteria 
  • How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process

Who Should Watch?

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the competitive landscape within the SVR. 

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge

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