May 26, 2022

Medtech Insight’s Guidance Tracker  

Author: Criterion Edge Writers

Staying current with national and international regulatory updates is a constant challenge for those in the medical device industry. Medtech Insight, already known for their website that provides up-to-date information with current trends and market data, has launched a new tool, the Global Medtech Guidance Tracker. This useful addition “comprehensively tracks regulatory guidance documents issued by medtech authorities from around the globe,” providing one location to read and search worldwide regulatory updates. 

The tracker is continuously updated, with new documents added every month. It organizes salient data by country, organization, and status (draft or final). Links in the tracker provide access to data, documents, and changes happening in real time. The tracker allows you to search data and original documents from 22 national and international regulatory organizations, including the Health Products Regulatory Authority (HPRA), European Commission (EC), and China FDA (CFDA).  

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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

Click here to watch the recording of this webinar.

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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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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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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March 31, 2022

[FREE WEBINAR] IVD Deep Dive Series Part 2

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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​

Who Should Watch?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of clinical performance reports for IVDR submissions.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge

Sign up for future webinars here.


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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March 28, 2022

[FREE WHITE PAPER] Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Overview

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.

Solution to Verify Device Safety and Performance

First, clearly understand the difference between safety and performance objectives and acceptance criteria. Then, use…

Download the rest of this white paper here.


Criterion Edge has the expertise and resources to write your Clinical Evaluation or Performance Evaluation Report. Ready for a free consult?

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