New release offers in-depth business perspectives on industry issues, compliance challenges and commercial opportunities authored by Nerac analysts
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- 54Issue: 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…
- 52Nerac helps identify a $300M market opportunity. Have a question for Kevin? Want to give Nerac a shot? Let us know!
- 51By 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…