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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May 18, 2022

Ask the Writers

Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies

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, will 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).

Participants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts!

Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

Who is this forum for?

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. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

Click here to watch the recording of this session.

Why is it important to establish state of the art during the clinical evaluation?

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.

If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can download our full whitepaper.

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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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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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