September 16, 2022

CER Critical Concepts

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

Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?

Click here to watch the recording of this session.

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:

  • Define each of these concepts and their relationship to each other
  • Develop MDR-aligned safety and performance objectives
  • How clinical outcomes are leveraged in the CER and how they are different from S&P objectives
  • Tying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)

There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also, we encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.

Critical Concepts: Measurable Objectives and Acceptance Criteria

This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.

Download the full white paper here.

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June 27, 2022

ATE: The Role of RA in the Clinical and Performance Evaluation Process

Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process

Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. In this session, we answer questions from many stages of the writing process, from the early planning stage through completion of all required written deliverables. Topics include early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, or how to identify potential roadblocks and proactively find solutions to common problems.

Click here to watch the recording of this session.

Who should watch this session?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?

In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff.

Read our blog post to help decide if outsourcing is the right decision for your team.

Key Strategies to Support Project Success for the Clinical and Performance Evaluation Process

Do you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant?

Download our free white paper, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

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June 2, 2022

The Role of RA in the Clinical and Performance Evaluation Process

The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success

Regulatory Affairs plays 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.

Click here to watch the recording of this webinar.

Key Takeaways:
1. Identify critical components of the clinical evaluation process and strategies to support project success.

2. Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process.

3. Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission.

There will be time at the end of the presentation to get your questions answered. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, answers will be limited to 3 minutes per question.

Who should register for this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?

In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff.

Read our blog post to help decide if outsourcing is the right decision for your team.

Key Strategies to Support Project Success for the Clinical and Performance Evaluation Process

Do you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant?

Download our free white paper, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

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May 12, 2022

Scoping Your MDR & IVDR Writing Projects

Scoping Your MDR and IVDR Writing Projects – The Forgotten Step

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

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

We hope to

  • Give insight into planning realistic timelines and assessing your team’s bandwidth to complete your project
  • Provide examples of key documents and inputs needed early in the writing process
  • Describe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates

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 Performance Evaluation 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 webinar.

6 Project Management Secrets Used by Top Medical Writers

I bet when you became a medical writer, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers, you’re not alone.

Click here to read these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements.

At Criterion Edge, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs. 

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