March 9, 2023

[FREE WEBINAR] Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation

Click here to watch the recording of this webinar.

The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But how should you approach the SVR when there is too much or not enough data?

This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.

Key Takeaways

  • How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.
  • How the systematic literature review process supports and connects the SVR, CPR, and APR by leveraging published data.
  • How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR.

Who are the Panelists?

Sarah J. Chavez, Director, IVD & Scientific Writing Services, Criterion Edge

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your scientific validity report or performance evaluation report. Ready for a free consult?

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February 28, 2023

Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation

the purpose of the SVR

The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But what is the purpose of the SVR, and how should you approach it when there is too much or not enough data?

This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.

In this webinar, you will learn
1. How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.
2. How the systematic literature review process supports and connects the SVR, CPR, and APR by leveraging published data.
3. How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR.

At the end of the presentation, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also, you can submit your questions at any point during the presentation.

Who should register for this webinar?

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

Click here to watch the recording of this webinar.

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

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

Watch Dr. Chavez’s recent webinar and benefit from key insider insights gleaned from this meeting. Sarah shares and discusses the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Many companies are in the early stages of planning for IVDR, so take a step towards IVDR readiness with these helpful suggestions for planning and preparation from the perspective of experienced regulatory writers.

Watch the webinar recording here.

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August 17, 2022

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

Author: Criterion Edge Writers

Regulatory Affairs (RA) professionals are poised to play a key role in supporting the clinical or performance evaluation report (CER or PER) process. Regulatory Affairs is active throughout the entire process, from pre-project planning through scoping and kick-off, report writing, review and sign-off, and finally, submission to the notified body.

How Can Regulatory Affairs Assist in the Clinical and Performance Evaluation Report Process?

The CER and PER are highly complex reports—not just because of the large amount of data they contain, but because they must tell a complex story. Putting all the evidence together for a successful submission is a difficult task, but RA is strategically positioned to provide critically important support and guidance to the evaluation writing team.

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February 8, 2022

IVD Deep Dive Series Part 1

Safety & Performance Objectives and Acceptance Criteria

How do I define acceptance criteria and how do I define safety and performance objectives?
What are the biggest pitfalls or “Achille’s heels” to watch out for in identifying safety and performance measures?

In this webinar, we’ll take a deep dive into the best practices to identify relevant and appropriate Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First, using a case study example, we’ll discuss considerations and provide tips to help you select relevant Safety & Performance Objectives for your IVD. Additionally, we’ll discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Then we’ll explain how these objectives help establish Acceptance Criteria, a critical input for establishing the SOA in your PER.

Watch the webinar recording.

Who should watch this webinar?

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

 

Key Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746

In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).

Overview of In Vitro Diagnostic Regulation 2017/746 

The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.

The transition into IVDR is already underway. Consequently, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one.

Read more on this topic in our blog post, here.

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February 8, 2022

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next, using our CE Scoping checklist, we will walk through the essential IVDR documents. Additionally, we’ll discuss SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.

Goals for this webinar:

  • Emphasize the importance of scoping
  • Discuss how to develop a checklist
  • Illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process

Who should watch this webinar?

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.

Click here to watch the recording of this webinar.

Leveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes

Watch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR?

Key takeaways from the discussion include:

  • Early implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies
  • What are the key documents and processes essential for successful alignment with IVDR regulations
  • The importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities
  • Unexpected roadblocks

Who should watch this webinar?

All regulatory, clinical, and scientific professionals who develop, write, review, or approve scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.

Watch the recording.

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[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.

Spots are limited – click to register for this free webinar.

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