State of the Art: Best Practices and Literature Review Using DistillerSR
In 2016, the European Commission released revision 4 of the MEDDEV guidance document 2.7/1 (“MEDDEV 2.7.1 rev 4”) to instruct manufacturers how to properly perform a clinical evaluation of a medical device.
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.
5 Key Questions to Help Manage Your Budget
This infographic goes through 5 key questions to go through in order to control your budget.
The Criterion Edge Model
Learn more about the experience and scalability of Criterion Edge.
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.
Intro to Adverse Event Webinar
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.