Data Sheets
Data Sheet
The Criterion Edge Model
Learn more about the experience and scalability of Criterion Edge.
Data Sheet
What We Do: Documents and Services
See our listing of the various documents and services we are experts in.
Infographics
Infographic
5 Key Questions to Help Manage Your Budget
This infographic goes through 5 key questions to go through in order to control your budget.
White Papers/Presentations
White Paper
State of the Art: Best Practices and Literature Review Using DistillerSR
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
White Paper
10 Strategies to Build Efficiencies in your Regulatory Writing Process
This piece discusses 10 key strategies to building an efficient regulatory writing process.
White Paper
Data Mining: New Initiatives on Health Care Data that Manufacturers Should be Watching
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
White Paper
MedDev 2.7/1 Guideline: More Clinical Evaluations?
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements
White Paper
MedDev 2.7/1 Guideline: Qualifications of Evaluators and Scientific Validity
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
White Paper
MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies
White Paper
Examining the Implications of the MDR on Data Management
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
Webinars
Webinar
How to Assess Your CER for MDR Readiness, Part 1
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
Webinar
Systematic Literature Review To Help Meet MDR Requirements
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
Webinar
Systematic Literature Review: How to Empower Data-Driven Decision Making
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Webinar
State of the Art Literature Review for EU MDR Compliance: How To Get It Right
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
Webinar
Intro to Adverse Event Reviews Webinar
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Webinar
Endpoint Adjudication by the Clinical Endpoints Committee (CEC) Webinar
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
Webinar
Advantages to Technologies Supporting Endpoint Adjudication Webinar
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the "JUDI" platform can simplify the management of adjudication.
Videos
Video
Experience & Scalability
Learn how Criterion Edge has both experience and scalability.