Nerac Announces the February Issue of the Nerac Strategist

New release offers in-depth business perspectives on industry issues, compliance challenges and commercial opportunities authored by Nerac analysts

EU Regulatory Compliance
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Issue: The client, a major cardiovascular stent company, wanted to ensure proactively that their intra-aortic balloon pump (IABP) catheters would comply with new EU regulations. Analyst Approach: The Nerac team reviewed over 1,000 publications to identify pertinent clinical research. A meta-analysis was performed on 260 applicable articles. Client Benefit: The analysis validated the efficacy of IABP catheters for certain…
Tags: analysis, clinical, issue, literature, nerac, read, compliance, evaluations
What benefit can clients gain from utilizing Nerac’s market research services?
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Nerac helps identify a $300M market opportunity. Have a question for Kevin? Want to give Nerac a shot? Let us know!
Tags: nerac, landscape, analysis, competitive
Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond
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By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC. In order for medical devices to be marketed in…
Tags: clinical, literature, compliance, nerac, evaluations, read, published, originally