Medical Device/Regulatory Support
Nerac’s team of analysts provide regulatory support to medical device manufacturers during and after market approval, with a focus on EU regulatory requirements. Nerac regulatory services include State of the Art Literature Review, Clinical Literature Evaluations, EU Clinical Evaluation Reports (CERs), and Vigilance Alerting/Period Literature Searches in support of Post-Market Surveillance Activities, as an input to risk management activities, and for ongoing preparation for CER updates.
As companies grapple with rising interest rates and tight cash flow, entrepreneurs, R&D managers, and startups are asking what are the right technologies to back? How do innovators quantify opportunity, value, and risk? More than just a patent landscape, Nerac has developed a methodology to help answer these questions.