By Rosemarie Szostak, Nerac Analyst,
Originally published September, 2013
he conflict minerals—tin, tungsten, tantalum and gold – can be found in products ranging from smart phones and warheads to textiles and toothpaste. Read more
What’s in Your Product? Understanding Conflict Minerals
Pre-Issuance Submissions under the America Invents Act
By Alan Kendrick, J.D., Nerac Analyst
Originally Published: July 23, 2014
The Leahy-Smith America Invents Act (AIA) was signed into law By President Obama in September 2011 and the final provisions became effective on March 16th, 2013. Read more
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
By Donna Mitchell-Magaldi, Nerac Analyst, On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the […]
The Costs of Regulatory Noncompliance in the Medical Device Industry: Is it Worth the Gamble?
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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Market Landscape – Energy
Issue: Nerac was engaged by a senior business development executive from a medium-sized energy manufacturing company to investigate options for entry into the biofuels market through a strategic acquisition. Read more
EU Regulatory Compliance
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. Read more.