Information That Drives Innovation
By Ron Sills, M.S., Nerac Analyst
Originally Published: April 7, 2014
A medical device company has requested that Nerac perform a pre-assessment audit of their debridement devices, which are a Class IIb product family, to assess compliance with the essential requirements of the Medical Devices Directive 93/42/EEC 2007, Annex IX, and with the company’s quality management system (QMS) certification per EN ISO 13485:2012.
This sample report demonstrates the findings of the review.
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By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: November 17th, 2014
The FDA has stated that labs can utilize published clinical data for their submissions. Many LDTs have been on the market for a while and have significant published data. Nerac has expertise in conducting clinical literature evaluations and data analysis to support regulatory filings and ongoing regulatory requirements. Read More
By Ron Sills, Nerac Analyst
Originally Published: September 29th, 2014
The European Union’s Council Directive 93/42/EEC concerning medical devices contains the essential requirements to be met by medical device manufacturers in order to market their products in the 28 member countries. Read more
By Donna Mitchell-Magaldi, Nerac Analyst
Originally published April, 2014
There are many resources available when gathering competitive intelligence. Read more
By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: July 21, 2014
Global economic weakness beginning in 2008, along with an aging population, has intensified the need to reduce healthcare costs. There is a general consensus that the rate of increase in healthcare spending is not sustainable. Since 2009, the annual rate of healthcare spending increases have dropped in the United States; however, it is not clear if this is a temporary phenomenon, or if spending increases will resume to previous levels as the economy improves. Read More
By Roz Sweeney, Ph.D. Nerac Analyst, The recent Supreme Court decision on the Association for Molecular Pathology v. Myriad Genetics case was the culmination of much litigation on the validity of […]
By Donna Mitchell-Magaldi, Nerac Analyst,
The global medical device market was valued at $350 billion dollars in 2012 (Mddonline.com, 2012).
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By Roz Sweeney, Ph.D. Nerac Analyst, Healthcare payers, both in the United States and Europe, have been striving to reduce costs in recent years, and this trend is expected to continue. […]
By Roz Sweeney, Ph.D. Nerac Analyst,
Comprehensive evaluations of the clinical and technical literature serve a variety of purposes for medical device companies.
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