Nerac Announces Addition to Analyst Team

New analyst brings experience in medical devices, neuroscience and biology.

The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
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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…
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Are Your Devices State-of-the-Art?
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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. A technical file for Class IIa and IIb devices, or a design dossier for…
Tags: devices, medical, read, analyst, originally, nerac, published, full
The Regulatory Environment for 3D Printing in the Healthcare Field
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By Erica Kramer, Ph.D., Nerac Analyst, Originally Published: January 19, 2017 The global 3D printing healthcare market is projected to grow to $2.3B by 2020, with medical and surgical centers expected to be the dominant end user segment. External wearable devices are expected to account for the largest market segment as a result of an…
Tags: medical, read, analyst, originally, nerac, published, devices