October 6, 2022

Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency

Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency

In this webinar, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices,” defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data.

Additionally, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.”

There will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. You can also submit your questions during the presentation.

Click here to watch the recording of this session.

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 anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.

Post Market Surveillance: Systematic Literature Review and Case Study

Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.

Key Takeaways:

  • How leveraging published data can help meet regulatory expectations and inform internal decision-making​
  • Steps for conducting a methodologically-sound SLR​
  • How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance.

Watch this free webinar here.

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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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September 3, 2022

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process 

In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy. 
 
How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device.

Click here to watch the recording of this webinar.

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 anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.

How to Empower Data-Driven Decisions in Your Organization

Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.

You can also watch our webinar on this topic.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology
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July 28, 2022

Bridging the Gaps: Clinical Data for GSPRs

Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs

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 will discuss the concept of clinical data sufficiency. Specifically, we will 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.

Click here to watch the recording of this webinar.

There will be time at the end of the webinar to get your questions answered. Please submit any questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may also send in your questions during the webinar.

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 anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.

How to Empower Data-Driven Decisions in Your Organization

Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.

You can also watch our webinar on this topic.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology
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February 16, 2022

IVD Deep Dive Series Part 2

Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report

In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD.

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR).

Key Takeaways:

  • Discuss the purpose of the CPR and its role as a critical component of the PER
  • Identify sources of clinical data and analyze those data within the context of the
    performance endpoints and acceptance criteria presented in the SVR
  • Demonstrate how to extract, organize, and appraise these data within the CPR

Watch the webinar recording.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical performance 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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