April 20, 2022

How to Establish the Competitive Landscape Within the Scientific Validity Report

In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed.

You will learn:

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

Who should attend?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission. Also, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend.

Click here to watch the webinar recording.

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

How can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.

This presentation will emphasize the importance of scoping, discuss how to develop a checklist, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process.

Watch the free webinar recording now.

Categories:
Do you like it?0
March 2, 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.

Categories:
Do you like it?0
February 23, 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.

Categories:
Do you like it?0
October 20, 2021

[Ask the Expert] Performance Evaluation Report

performance evaluation report

This session’s topic: The Performance Evaluation Report (PER)

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?

During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the role of the State-of-the-Art section within the PER, whether using a PER template is right for you including what the notified body expects to see, and the methodology and strategy for PER, PEP, and PMPF plans.

Who should watch this webinar?

Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.

Watch the recording!

What You Need to Be Compliant

Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.

Categories:
Do you like it?0
October 6, 2021

[Ask the Expert] Performance Evaluation Report

performance evaluation report

This session’s topic: The Performance Evaluation Report (PER)

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?

During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the biggest pitfalls to look out for when writing a PER. In addition, they discuss how to align your internal processes and systems to comply with rigorous IVDR regulations and what technical documents are required for the PER, PEP, and PMPF.

Who should watch this webinar?

Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.

Watch the recording!

What You Need to Be Compliant

Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.

Categories:
Do you like it?0