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Criterion Edge leads the way with
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Need Scalability on your next Regulatory Writing Project?
One of the realities that your team is faced with every day is pressure. Pressure from competing project priorities, looming deadlines and the unanticipated.
“Doing more with less” is the new imperative. We can help. The CEI team of specialized medical writers provides you with the flexibility needed to meet your medical and regulatory writing requirements.
Resources
The Criterion Edge Model
Learn more about the experience and scalability of Criterion Edge.
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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 for compliance.
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Developing the state of the art section of the CER: challenges and pitfalls
At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will […]Read MoreWhy is it important to establish state of the art during the clinical evaluation?
At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will […]Read More
