Learn more about the experience and scalability of Criterion Edge.
What We Do: Documents and Services
See our listing of the various documents and services we are experts in.
5 Key Questions to Help Manage Your Budget
This infographic goes through 5 key questions to go through in order to control your budget.
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.
10 Strategies to Build Efficiencies in your Regulatory Writing Process
This piece discusses 10 key strategies to building an efficient regulatory writing process.
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
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
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.
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.
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.
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.
Experience & Scalability
Learn how Criterion Edge has both experience and scalability.